- Carries out QA inspection of starting and packaging materials, in-process and finished materials.
- Carries out sampling of starting and packaging materials, in process and finished materials.
- Performs room release and batch sign in for manufacturing operations
- Carries out and monitor established QA/GMP programmes.
- Carries of Environmental Monitoring and trending
- Gives assistance in the retain system for samples and documents.
- Carries out Batch Manufacturing Review and review of batch related documents.
- Provides assistance in departmental and regulatory audits.
- Has the ability to train a colleague in a particular GMP procedure or related activity.
- A third level qualification in a scientific discipline, preferably a B.Sc./M.Sc.
- At least two years pharmaceutical experience with good working knowledge of cGMP.
- Strong knowledge of FDA/EMEA regulatory requirements.
- Excellent organisational, communication and interpersonal skills.
- Ability to set and maintain the highest standards.
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