Location

Switzerland

Job Description

• Support the implementation of the standardized procedures, processes and systems for CAPA.
• Deliver education and interactive training for CAPA users to deliver consistent compliant CAPAs including Failure Investigation, CAPA Review Board and CAPA content.
• Assist CAPA users with development and documentation of problem statements, containment and correction, root cause, and action plan (including effectiveness monitoring) determination.
• Maintain overall management and effectiveness of the CAPA system including the process and application for the site.
• Roll-out and maintain site CAPA Review Boards including scheduling, execution and minutes.
• Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to CAPA.
• Provide CAPA compliance metrics and weekly management tracking report.
• Implement measures to monitor the effectiveness of the CAPA system. Ensure results of verification and monitoring of the effectiveness of CAPA and its compliance to applicable regulations and standards of monitoring process are routinely communicated to management.
• Facilitate Change Management activities resulting from the standardization of the CAPA process and associated systems.
• Liaise with EU CAPA Manager in establishing and implementing policies, procedures, and quality objectives.
• Liaise with the EU CAPA Manager to align on system requirements to support the CAPA process.
• Identification and leadership of tactical continuous improvement opportunities.
• Identify opportunities for procedural harmonization and integration. Identify and establish best practices, ensuring best practices are utilized throughout Global Orthopaedics.
• Partner on the formulation of responses to regulatory agencies in order to address CAPA related observations. Collaborate in the identification and implementation of corrective actions. Ensure effective and timely completion of all corrective actions.
• To adhere to the company’s procedures as detailed in the sop manual.

Profile

• Excellent communication skills, to quickly build credibility within the Quality and Compliance community, executive management, external regulators, and industry – Both verbal and written
• Excellent presentation, facilitation and training skills
• Strong collaboration and influencing skills to partner effectively with other functions and across sites
• System design and management skills – Organizational and Quality Systems
• Expert knowledge of the US Quality System Regulations and ISO 13485
• Demonstrated track record of delivering best in class results in the Quality Systems area
• Fluent in German and in English – able to interact, generate processes and procedures and educate and train
• Strong knowledge of quality and compliance for Medical Device Industry (GMPs).
• Working knowledge of Quality System Regulations.
• A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
• Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
• Demonstrated knowledge of business impact of compliance issues and risk management

Offer

• A position with responsibility within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

The post CAPA Consultant appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Location

Kempen

Job Description

• Monitor and control compliance and validation
• Produce and manage relevant compliance and documentation
• Review and validate project documentation and procedures
• Support testing and validation phases, managing and support business analyst to generate test scripts
• Manage and document results of different test phases
• Qualification planning and cooperation with project teams to ensure qualification activities are performed and reporting of project compliance status
• Maintenance and review of qualification documents and coordination of corrective actions Assist team in implementation and setup of scrum/agile development lifecycle
• Produce and own compliance documentation for the project
• Monitor and assist in system validation
• Environment Development Tool(s) and Platform(s)
  • SCRUM/Agile tools that support user stories, product backlog and testing in big scale SaaS projects
  • Salesforce.com project experience

Profile

• Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience
• Know and understand compliance and data privacy areas in the context of pharmaceutical business
• Expertise on Business/System Analysis
• Expertise on managing big scale project through SCRUM/Agile methodology
• Knowledge of testing practices, (experience with HP Quality Centre is a plus)
• Good Manufacturing/Clinical/Laboratory Practices (GxP) regulation, you have worked in environments that are subject to GxP and participated in activities that ensure GxP compliance (+3 year)
• Easily analyze processes, draw flow chart diagrams and describe processes in clear language. You have excellent (technical) writing skills (+3 years)
• Excellent ability to process and analyze data in Microsoft Office tools like Excel and SharePoint (+3 years)
• SDLC/PMP/PrinceII/ITIL certification is a plus
• Knowledge of SalesForce.com and Siebel CRM
• Risk management helping the team to anticipate and mitigate project risk Methodology/Certification requirements (standardized)
• Accepts personal responsibility to commit to tight implementation timelines
• Excellent interpersonal, communication and team collaboration skills
• Ability to define and communicate process and guidelines for rest of the team
• Dutch and English spoken and written

Offer

• A position with responsibility within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

The post SaaS Compliance and Validation Senior Analyst appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Location

Switzerland

Job Description

• Perform CAPA Legacy Reviews per protocol per schedule
• Engage with local CAPA and site process SMEs to ensure adequate review of CAPA content and product and process risk
• Alert management of product quality & compliance issues for proper and timely escalation to CAPA
• To adhere to the company’s procedures as detailed in the SOP Manual

Profile

• Strong knowledge of quality and compliance for Medical Device Industry (GMPs)
• Working knowledge of Quality System Regulations
• A good working knowledge of related functions such as Operations, Supplier Management, Product Development and Procurement
• Experience in FDA QSR and ISO 9001/ISO 13485 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards
• Demonstrated knowledge of business impact of compliance issues and risk management
• Proven ability to build partnerships both internally and externally
• Strong collaboration and influencing skills to partner effectively with various functions and across Operating Units – Both Internally and Externally
• Expert knowledge of the US Quality System Regulations and ISO 13485
• Demonstrated track record of delivering best in class results in the Quality Systems area
• Fluent in German and in English – able to review CAPA documents & interact with CAPA & site process SMEs

Offer

• A position with responsibility within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

The post EU CAPA Legacy Review Consultant appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Location

Switzerland

Job Description

• Sourcing Strategy Implementation – approx. 40% of time/effort
  • Develop in-depth knowledge about Supply Base Industries (Industry Analysis, Supply Analysis and Segmentation, Sourcing Choice)
  • Become the point of contact in the EMEA supply base area for Industry and Supplier intelligence and trends
  • Develop, align with Business and execute sourcing strategies for the specific technology area
• Competitive Bidding and Negotiations – approx. 20% of time/effort
  • Ensure alignment on the competitive bidding thresholds across the regional plant network
  • Ensure procurement is involved early in appropriate CCFS investment decisions (Medium – High Value investments) and that competitive bidding events are run according to standard regional operating procedures
  • Provide support in the plant purchasing negotiations as appropriate (depending on the size of the investment)
• Supplier Relationship Management – approx. 20% of time/effort
  • Accountable for defining and managing key EMEA supplier relationships to best meet the needs of the business
  • Accountable for the identification, implementation and tracking of Continuous Improvement initiatives at selected suppliers
• Legal Contract Development and Management – approx. 10% of time/effort
  • Support in the development of appropriate supply terms, penalties and incentive agreements for suppliers to maximize levels and value for money service
  • Ensure appropriate legal coverage is maintained across the portfolio
• Supplier Base Optimization (SBO) – approx. 10% of time/effort
  • Work on reducing the number of suppliers in the CBS Procurement area by leveraging on existing EMEA / Global X-sector initiatives

Profile

• Actual cost savings, cost avoidances in current projects as validated by the manager and financial business partners – for company plants and external contract manufacturers
• Project pipeline containing cost savings and cost avoidance opportunities for future projects at both the company plants and External Contract Manufacturers
• Regional plant Compliance to EMEA Procurement SOPs
• Structural supplier responsiveness and reliability improvements in the current and future supply base
• Other Dimensions:
  • The SSE Sourcing Managers will represent the company extensively with external companies, and must maintain strict discipline with regard to confidential/sensitive information and must maintain a strong code of ethics
  • The SSE Sourcing Managers will be interfacing and negotiating with senior management at the Suppliers
  • The SSE Sourcing Managers will act as consultants to senior level management and franchise leadership teams in the areas of current and future supply trends

Offer

• A position with responsibility within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

The post Procurement Sourcing Manager appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Het team bestaat momenteel uit 9 personen: .NET developpers, .NET architect, analisten, testers, projectleider. Omwille van de kriticiteit van de toepassing en de interactie met de vele operationele tools is er een senior IT Project Manager nodig die onderstaande taken dient uit te voeren.

Locatie

Brussel

Functie

• Leadership en volledig beheer van het IT project, zoals het initiëren en opvolgen van de subprojecten, het opmaken van een implementatieplan, opvolgen van de scope, budget en timing, beheer van issues en actielijsten, risico’s, voortgangsrapportering in steering committee, meting van het resultaat, KPI’s, maandelijkse markante feiten, …
• Het aansturen van een team interne en/of externe ontwikkelaars in samenwerking met de technische verantwoordelijke voor .NET implementaties.
• Organiseren van de meetings: wekelijkse projectteammeetings, steering committee meetings samen met business. Opstellen meeting minutes.
• Uitvoeren van de microplanning van development en testing en valideren macroplanning die door de business projectleider onderhouden wordt.
• Het uitvoeren van analysetaken in functie van beschikbare tijd voor de andere opdrachten.
• Projectopvolging van het CC2 project. De CC (company & contract) toepassing wordt momenteel herschreven, maar het domeinmodel werd grotendeels veranderd om het meer coherent te maken met de business processen. CC is een master data systeem van de elektriciteitsmarkt op TSO niveau. CC is verbonden via webservices met een groot aantal tools die operationele processen (zoals scheduling) beheren. Bij de migratie van CC1 naar CC2 mogen er geen onderbrekingen gebeuren van de operationele processen. De deadline voor het herschrijven van de volledige code is eind februari 2014. Een deel is reeds herschreven en de herschreven code wordt progressief in dienst genomen. Het doel van het project is te beschikken over een nieuwe code die conform is aan het Partner IT .NET framework en die een snellere aanpassing van de regels van de energiemarkt zal mogelijk maken. Het respecteren van de timing is belangrijk omdat de regels van de energiemarkt voortdurend veranderen en sommige processen na een bepaalde datum niet meer manueel beheerd kunnen worden.

Profiel

• Je kan uitpakken met een aantal jaar relevante ervaring als projectleider en IT analist, dit voor IT-projecten gebaseerd op een Microsoft architectuur (.NET, Visual Studio, SQL Server).
• Je kan op technisch vlak makkelijk met de ontwikkelaars meepraten.
• Je bent tweetalig Nederlands/Frans en hebt een zeer goede kennis van het Engels.
• Je hebt een analytische geest en een goed organisatietalent.
• Je klantgerichte aanpak sluit perfect aan bij je communicatieve persoonlijkheid en je werkt vlot in een team.
• Ten slotte volg je de IT-technologische evolutie op de voet.

Aanbod

• Een verantwoordelijke positie binnen een toonaangevend internationaal bedrijf
• Voldoende persoonlijke ontwikkelingsmogelijkheden on the job en door bijkomende externe opleidingen
• Een marktconforme verloning, aangevuld met een pakket van extralegale voordelen

The post .NET IT Project Manager appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Location

Kempen

Job Description

• Plan, lead, drive and follow up the activities required for setting up the technical environment and implementing the system. This requires coordination with the SAP COE, Infrastructure (ITS) and the database teams.
• This includes the planning of all hardware and software installation required for this project, including authorizations
• Some examples of activities to plan/coordinate/test:
  •  Hardware sizing for a singled threading application
  • Setup VM box, Citrix box + admin accounts
  • Install database with input of OMP
  • Execution of various database scripts with input of OMP
  • Setup MBOX from various sources of supply towards OMP
  • Install OMP software on VM boxConfigure new AD groups (+initiate the creation in the assignment tool)
  • Install scripting software that checks if the application is still active/responding within the thresholds
  • SAP – setup logical system towards OMP, configure QOUT, setup RFC towards OMP
• Plan and coordinate all infrastructure and software related installation work for the project
• Raise and follow up al installation requests
• Coordinate the installations, so that they are executed on time and in an efficient manner
• Develop a strong understanding on the solution proposal
• Understand and evaluate business requirements, translate them into functional specification and technical design
• Perform hands-on configuration and instruct ABAP programmers
• Define unit test scenarios and execute unit testing
• Document test scripts and test evidence in testing tool (HP Quality center)
• Define integration test scenarios and execute integration testing
• Document the scripts and evidence in the testing tool
• The integration tests include both SAP ECC and OMP+
• The tests needs to be executed cross system by the candidate
• Assist business users during UAT
• Perform regression test scenarios for testing the existing functionalities against changes
• Provide post go-live support and drive the smooth transition of the support to the respective teams
• With the other team members, be accountable for on time delivery of the project deliverables

Profile

• Strong knowledge about supply chain planning and production planning in SAP is required
• Senior level Sap ECC MM and MRP: Excellent knowledge of the SAP MM, MRP and PP-PI module
• Good knowledge about SAP POI (production optimization interface)
• Good knowledge about IDOC process, IDOC enhancements and related functionality
• At least 5 to 8 year of experience working with hands on SAP consulting
• Minimum 3 years of experience with SAP MM, SAP MRP, SAP PP-PI, SDLC, ABAP, IDOC
• Minimum 3 years of experience with working in GxP environment
• Minimum 7 years of experience with SAP ECC and SAP POI Interface
• Experience with linking external planning system to SAP ECC (via POI) is considered as an asset
• Experience in working with a virtual team and collaboration with off-shore ABAP team
• Experience in working with an international environment, with key users located across different geographical regions
• Be able to work in a complex technical environment, including an external planning and scheduling system (OMP+), to be integrated with SAP ECC via the POI Interface
• The candidate will have to learn the basic OMP+ transactions and functionality, in order to be able to execute integration test in an efficient and flexible way
• Functional skills: Have a good functional understanding about SCM processes: should be able to translate business requirements into SAP solution
• Should possess good documenting skills: specifying the solution clearly in functional and technical design documents. Identify test cases to test the solution. Translate functional and technical design to appropriate test scripts
• Required strong adherence to the SDLC
• Strong coordination skills in a technical environment are required
• Some flexibility in working hours is required (occasional over-time or weekend/holiday work)
• Excellent communication skills towards key users on functional level
• Strong analytical and problem-solving skills
• Must be able to work on multiple simultaneous tasks with limited supervision
• Quick learner, motivated self-starter
• Able to understand and adhere to change management procedures and internal guidelines
• Occasional project related travel is possible
• Very good knowledge of English, both written and spoken

Offer

• A position with responsibility within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

The post Project Team Lead appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Location

Brussels

Job Description

• Coordinating between IT and the various entities involved in the project
• Setting up project governance
• Assessing the feasibility of IT projects
• Pinpointing your customers’ needs and convert these into an explicit project plan
• Making agreements clear, on the one hand with the customer, and on the other hand with the development team
• Guiding and motivating all persons involved in the project in order to achieve good results
• Guaranteeing that all procedures, legal requirements and quality standards are rigorously respected
• As project leader IT you have the final responsibility for delivering the project results
• Giving clear information and reporting about the progress of the IT project to the relevant stakeholders on a regular basis

Profile

• Master degree, or equal through experience
• Experience in project management and you have an affinity with IT
• Good knowledge about personal productivity tools (Word, Excel, PowerPoint, Visio) and planning tools (MS Project)
• Knowledge of the financial sector is a plus
• Knowledge of OFSAA is a plus (Oracle platform)
• Excellent communicator, both oral as written, as you play a key role in information sharing
• Systematic and capable to work autonomously, you can set priorities while remaining focused on the targets
• Customer-oriented and resilient, your project needs to satisfy all parties involved-responsible
• Able to work under pressure to deliver timely the agreed result and quality
• Excellent written and spoken knowledge of English; knowledge of Dutch and/or French is an asset

Offer

• A position with responsibility within a leading international company
• Personal development through learning on the job and additional external trainings
• A market oriented compensation, including a range of fringe benefits

The post IT Project Leader appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Locatie

Antwerpen

Taken

• Uitvoeren van equipment kwalificatie (lab equipment)
• Uitvoeren van methode validaties en methode transfers
• Analytische ondersteuning bij problem solving

Profiel

• Master of PHD in Wetenschappelijke richting, bij voorkeur Scheikunde of Bio-Ingenieur of gelijkwaardig door ervaring
• Kennis van chromatografie: HPLC, GC, …
• Relevante kennis van andere analytische technieken
• Kennis van Empower chromatografie software is een meerwaarde
• Ervaring met methode validaties en methode transfers
• Kennis van ICH guidelines rond methode validaties
• Ervaring met kwalificatie van labotoestellen
• Goede kennis van Nederlands en Engels
• Vlot kunnen werken met PC en toepassingen zoals Word, Excel, Powerpoint
• Teamplayer
• Proactief in het aanpakken van problemen en grondige analytische kennis bij het oplossen ervan
• Zeer accuraat, groot verantwoordelijkheidsgevoel, quality minded

Aanbod

• Een verantwoordelijke positie binnen een toonaangevend internationaal farmaceutisch bedrijf
• Voldoende persoonlijke ontwikkelingsmogelijkheden on the job en door bijkomende externe opleidingen
• Een marktconforme verloning, aangevuld met een pakket van extralegale voordelen

The post Project Engineer Chemisch Labo appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Locatie

Werven in Vlaanderen

Functie

• Vergezellende bediende van goederen trein (baantreinbegeleider)
• Schildwacht
• Overwegwachter
• Houder veiligheidsboekje
• Buitenspanning stelling van de bovenleiding volgens bericht
• Begeleiden van werktreinen naar, op en van een spoor buiten dienst
• Uitvoeren van schouwing van een werktrein en detecteren van de ‘gemakkelijk op te sporen’ onregelmatigheden
• Uitvoeren van verrichtingen met betrekking tot het samenstellen van een werktrein
• Uitvoeren van de remproef
• Controleren van de verschillende voorwaarden waaraan een werktrein moet beantwoorden voor het vertrek (remming, samenstelling, snelheid, last)
• Overschrijden van overwegen in alle veiligheid op een spoor buiten dienst
• Beschikken over de nodige kennissen voor het gebruik van de spoorweginfrastructuur
• De veiligheid van een werf verzekeren als schildwacht

Profiel

• U heeft interesse voor de spoorwegsector en voor de veiligheidsaspecten
• U bent flexibel (uurrooster en verplaatsingen)
• U bent zich bewust van veiligheid op het werf
• Reeds in het bezit zijn van het brevet van vergezellende bediende goederen- / werktreinen is een pluspunt
• Vlot Franstalig of Nederlandstalig

Aanbod

• Een verantwoordelijke positie binnen een toonaangevend internationaal bedrijf
• Voldoende persoonlijke ontwikkelingsmogelijkheden on the job en door bijkomende externe opleidingen
• Een marktconforme verloning, aangevuld met een pakket van extralegale voordelen

The post Veiligheidmedewerker Werf appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.

Locatie

Antwerpen

Functie

Organisatie en management van investeringsprojecten. Ontwerpen, bouwen en opleveren van een farmaceutische productie eenheid bestaande uit productie equipment met bijhorende ondersteunende technische installaties en gebouwen. 

U bent verantwoordelijk voor:

• De overkoepelende coördinatie van het project
• Opstellen, beheren en rapporteren van de projectscope, het projectbudget en de projectplanning in overleg met interne klanten, leveranciers, stakeholders en bestaande overlegstructuren
• Opstellen van het projectcharter, de projectplanning, samenstellen en begeleiden van het project team naar de vastgelegde projectdoelen
• Afstemming met resource- en afdelingsmanagers aangaande de staffing van het project
• Opzetten en bewaken van communicatie structuren met alle betrokken interne en externe “project”-klanten en betrokken operationele afdelingen gedurende het hele projectverloop
• Overdracht van het project aan productie- en onderhoudsafdelingen

Profiel

• Masteropleiding in een technische discipline: industrieel ingenieur, burgerlijk ingenieur, bio-ingenieur, …
• Ervaring met het leiden van engineering projecten van ontwerp (conceptueel, basis en detail) tot het valideren en opstarten van plants in de pharma is een vereiste
• Kennis van project management systemen en tools (MS Project Server)
• Sterke planning, communicatie en organisatorische vaardigheden
• Teamspeler en teamcoach
• Analytisch, nauwgezet, zelfstandig
• Probleemoplossend vermogen
• Flexibel (bereidheid tot werken buiten normale daguren)
• Zeer goede kennis Nederlands en Engels

Aanbod

• Een verantwoordelijke positie binnen een toonaangevend internationaal bedrijf
• Voldoende persoonlijke ontwikkelingsmogelijkheden on the job en door bijkomende externe opleidingen
• Een marktconforme verloning, aangevuld met een pakket van extralegale voordelen

The post Project Leader Engineering appeared first on Consultancy & Projects in Engineering, Pharma & IT - Pauwels Consulting.