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Quality Assurance Officer

Michael Bailey Associates - Amsterdam

Posted on Mar 28, 2021 by Michael Bailey Associates - Amsterdam

Amsterdam, Noord-Holland, Netherlands
Research
Immediate Start
Annual Salary
Full-Time


Quality Assurance Officer - Pharmaceuticals


Here at MBA we're representing an industry leading Pharma manufacturer that's looking for a Quality Officer to join our team based in Amsterdam, The Netherlands. The candidate will be supporting the Quality Manager in the development of their PQS (pharmaceutical quality systems).


The quality assurance officer will also oversee the management of processes that enable the assessment quality within the Contract Manufacturing (CMO) network to be tracked, managed and trended enabling effective communication to key stakeholders within DPM&S and the wider business.


Quality Assurance Officer - Responsibilities


So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:



  • To develop/review existing procedures to ensure all processed. Good distribution practices (GDP)

  • To support the review of quality deliverables from External Network facilities confirming quality expectations while demonstrating maturity, integrity experience and knowledge of subject

  • To support the Quality Manager in the definition, development, implementation and refinement of appropriate Key Performance Indicators (KPI's) for senior management in order to monitor the effectiveness of the PQS

  • To support the Quality Manager where required with Product Quality Reviews (PQR's) and Quality Technical Agreements (QTA's)

  • To support the Quality Manager in the management in recalls, complaints, change controls, deviations, CAPA activities as required

  • To review External Network specifications, batch manufacturer, packaging, testing and validation activities for compliance against current GMP expectations and marketing authorisations

  • To support the Quality Manager on CMO projects, new technology and technical transfer within CMO network and associated validation, problem shooting including liaising with technical, commercial and supply chain stakeholders

  • To provide quality guidance in order to ensure Good Distribution Practice (GDP) across the supply chain and to ensure quality adherence across the supply chain in its entirety

  • To contribute to manufacturing, supply chain and technical services in daily work, projects and programmes, with the focus being to ensure quality is Embedded at all stages of products from New Product Introduction (NPI), transfer, manufacture and distribution.

  • To ensure effective communication with to drive the quality agenda, to liaise and co-operate with all other departments to ensure good communication and timely identification and resolution of issues

  • To report and create action plans, as necessary on changes in standards (internally and externally initiated) and on performance against standards

  • To liaise with suppliers with respect to quality incidents in supporting existing business and to provide quality oversight of new product introductions and technical transfers within the CMO network

  • To support and plan Supplier, Regulator and Customer audits


Quality Assurance Officer - Responsibilities


embrace candidates from all walks of life. We're particularly keen to here from those who have/are:



  • Demonstrated pharmaceutical quality experience, including working within quality systems such as audit programmes, change control, complaint handling and Investigations

  • A thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements

  • Experience of supporting audits and self-inspections

  • Appropriate, relevant Quality Assurance experience

  • Proven quality specialist capabilities in a quality role associated with CMO management


If you are interested in this vacancy please email or call


Michael Bailey International is acting as an Employment Agency in relation to this vacancy.




Reference: 1144051763

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