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Qualified Person (Biologics)

Job description

Job Responsibilities
-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.
-ATPM knowledge.

Should you be the qualifying candidate and are interested in this job, please contact Andrius at (01) 4744 692 or at aantanaitis@sigmar.ie

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