about this position
Responsible for QA activities in the company including CMC, pre clinic, bioassay and clinical QA
Duties
- To implement standards, methods and procedures in CMC processes
- To follow in-house and external GMP manufacturing and support all related QA activities
- Determine the requirements for documentation, materials, training, equipment.
- To review and approve production batch records, Batch release
- To lay down procedures for the preparation, approval, authorization, control and revision of SOPs
- Responsible for training and implementation of SOPs
- To maintain environmental monitoring tracking and trending, perform internal investigation in case of deviation.
- Lead investigations related to Manufacture process / Equipment, CAPA’s, Change Control.
- Review and approve calibration, IQ, OQ, PQ reports.
- Review submission documents to ensure organization, clarity, accuracy, format and consistency.
Requirements
- Bachelor's Degree or higher within the Life Sciences space
- 2+ years of experience within a quality role in a biologics focused environment
- Experience in GMP manufacturing activities as review of batch records, OOS, CAPA, etc.
- Expertise in GMP; strong working knowledge of FDA & EU and ICH regulations in relation to the manufacturing of biologics – an advantage
- Participation in preparation of applications to regulatory authorities – an advantage
- Excellent written English skills
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