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GMP QA Associate
To further strengthen our Quality team, we are looking for an experienced and motivated GMP QA Associate. The GMP QA Associate will play a role in further build out of GMP quality infrastructure at the organization in close collaboration with internal business teams.
Key Accountabilities and Responsibilities:
The role is responsible for performing duties related to the management of records relevant to the review and release of Batch Records, working in close collaboration with the manufacturing teams and GMP Quality Managers:
- Coordinate the batch record review and approval process ensuring timelines are met
- Review of executed batch record documentation of clinical and commercial Drug Substance and Drug Product batches
- Review batch record documentation and support release of finished IMP for clinical studies
- Support release of commercial product
- Review of deviation investigations related to manufactured batches and related corrective and preventive actions
- Monitoring of the performance of the manufacturing processes through metrics
- Ensure Quality goals are met and all practices and procedures comply with company policies and applicable regulations
- Contributes to internal and external audit planning and follow-up.
- Support the further build-out of quality processes and systems.
The role may also support the QA team with additional ad hoc project support.
Desired Skills and Experiences:
- Master’s degree in a scientific discipline or equivalent through education and experience, preferably a pharmacist
- Minimum 2 years’ experience in GMP/batch record review, dealing with biopharmaceuticals with experience in biological manufacturing
- Experience with audits is a
- Good knowledge of FDA and EU regulations and ICH
- Quality attitude; can do mentality;
- Good organization and planning skills;
- Strong communication skills and able to build relationship with business partners and to work effectively together with others;
minimum 3 years
Submit your CV
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