Manages pharmaceutical quality assurance activities, including GMP compliance, quality management systems, SOP development, equipment and process validation, batch record review and release, internal audits, and preparation for regulatory inspections.
Core Roles of QA in Pharma
Requirements
GMP Compliance Ensures adherence to Good Manufacturing Practice regulations (FDA, EMA, ICH guidelines) throughout production.
Quality Management System Develops, documents, and maintains SOPs, policies, and manuals to integrate quality into every process.
Validation & Qualification Confirms that equipment, processes, and systems consistently perform as intended.
Batch Release Reviews and approves batch records before products are released to the market.
Audits & Inspections Conducts internal audits and prepares for external regulatory inspections.
Requirements
- Bpharm graduates
- Quality assurance knowledge
- Basic pharmocology
- Quality assurance experience
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