For one of my clients in biologics, I’m searching for someone that can be responsible for QP batch certification and Quality oversight of third party manufactured branded products while ensuring proper quality oversight to monitor compliance of key contract manufacturers. This is a very challenging role where you can gain a lot of experience in a broad spectrum of the drug life cycle. Furthermore, you’ll be involved with QA on a global level, a real career booster to open a lot of future opportunities.
* QP Batch certification of pharmaceutical branded and Biological products ensuring compliance with GMP and the marketing authorizations.
* Quality oversight of manufacturing operations at the CMOs and support from a QA technical perspective technology transfers, process validations, analytical testing and new product introductions etc.
* Review and approval of change control notification received from third parties while liaising in a timely manner with internal stakeholder (e.g. RA, Supply, management etc.) to ensure on time authorities notification and maintenance of applicable marketing authorizations.
* Management (initiate and investigate) all quality issues associated with the manufacturing, testing and release of Drug Products or Medical Devices originating from assigned CMO´s (e.g. complaints, deviations, OOS , recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion and when applicable coordination and immediate implementation of any drug recalls.
* Management of Team Biologics & Pharma Branded supporting Biologics and Pharma branded operational and release activities.
* Timely completion and approval of annual product review (APR/PQR) for the product under QA B&CM responsibility.
* Negotiation and maintenance of Quality technical agreements with CMOs/CSPs.
* Ensures the sites used as third parties for manufacturing testing and storage of API and medicinal product are maintained in a qualified state by planning and executing external audits.
* Ensuring that the distribution of medicinal products complies with Good Distribution Practice (GDP).
* Main point of contact for all QA related topics intern and externally.
* Participate (Co-hosting) authorities’ inspections towards the maintenance of the MIA of the site.
* Ensure local QMS is maintained up to date in accordance with Global standard policies, relevant regulations, new trend and industry standard.
* Support of Quality KPIs generation and trending as support for periodic Quality management review board
* Ensure timely escalation to management of key quality issues while bringing proposals for resolution and impact mitigation in line with corporate standard and relevant local regulation.
* Preparation and execution of GMP/GDP training for employees.
* BSc and MSc in (Bio-) Chemistry, Pharmacy, Industrial pharmacy, Biotechnology or similar
* Minimum of 10 years of relevant experience in GMP regulated environments (EU GMP/CFR) involved in the sterile manufacturing of pharmaceutical drug products for human use.
* Experience as Qualified Person for minimum of 4 years
* Experience with Medical Devices and Biopharmaceuticals is a plus
* Strong knowledge of EU GMP, US CFRs.
* Fluency in English.
* Market conform salary
* Flexible working hours
* Global responsibility boosting your career into a higher level
* Broad spectrum of responsibilities from clinical to market release so you will not be feeling like you are in a box
* Exciting and growing environment providing you’re the opportunity and space to grow into your full potential
If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!