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Quality Assurance Manager (Pharmaceutical)
Responsibilities:
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Manage the quality systems to
ensure compliance with Good Manufacturing
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Practices (cGMP), regulatory
agencies, client and corporate expectations.
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Verify and approve all cGMP
documents
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Host client audits
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Assist in conducting
investigations including review and evaluation of
related Corrective Actions/Preventive Actions (CAPA’s).
Requirements:
- Minimum MSc in Chemistry or a related scientific
discipline
- Significant experience (minimum 5 years) in quality
assurance and regulatory affairs, preferably within the API and/or
pharmaceutical manufacturing industry.
- Minimum 7 years of prior experience in a cGMP and Good
Laboratory Practices (GLP) environment.
- Track record of operational leadership
- Project management experience
- Knowledgeable in dealing with FDA, TPD and other
international regulatory agencies.
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