GMP Compliance - Senior
Life Sciences
QA
- Location
- Wavre, Walloon Brabant
- Work type
- Consultancy
- Work model
- Fulltime, Hybrid
As a QA GMP compliance support, you will be working closely with the External Quality department. You will act as a Person-in-Plan (PIP) at a CMO located in Germany (Westphalia) to have a QA oversight of the manufacturing of clinical batches and support the follow-up of deviations at CMO site.
Responsibilities
As a PIP at a CMO, your mission will be to :
- Ensure that clinical batches are manufactured according to GMP’sand Quality Agreement (witness batch manufacturing on the shop floor for critical sterility assurance steps as sterile set up and filling + make GEMBA’s to ensure compliance of the process whenever needed)
- Escalate any critical issue observed during the PIP
- External Quality and assess the impact with the CMO
- Process at CMO = DS thawing - compounding –filling / freeze-drying / capping / visual inspection / storage
- Support the investigation and closure of the deviations + associated CAPA’s
- Report progress daily to Managament
Requirements
- University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
- Min. 5 years of experience in Pharmaceutical Industry associated with a GMP background
- Experience in QA or production department, with expertise in the field, in quality systems or release.
- Good knowledge of the pharmaceutical current best practices in Drug Product manufacturing technologies, GMP compliance, sterility assurance
- Fluent in written and oral English is mandatory, German speaking is a plus
- Excellent communication and influencing skills.
- Ready to travel extensively to CMO located in Germany (90 to 100% of the time)
Offer
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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