-Management of batch disposition and material status control.
-Review and record of essential documentation and SOPs.
-Provide support to QA team.
-Support both, the internal and external audits.
-Ensure compliance according to cGMP practices.
-Ensure compliance with specific regulatory frameworks.
Essential Job Requirements
-Primary Scientific degree.
-Education requirements to satisfy EU directive 2001/83/EC of a Qualified Person.
-5 years’ experience in QA.
-Experience in sterile manufacturing is essential. Previous Biologics experience is an advantage.
-GMP knowledge as per FDA and EMEA regulation for oral solid dosage pharmaceutical manufacturing.
Should you be the qualifying candidate and are interested in this job, please contact Andrius at (01) 4744 692 or at firstname.lastname@example.org
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