Executive -Manager For QA (Quality Assurance ) IN API Pharma Ahmedabad

QA- QUALITY ASSURANCE EXECUTIVE /MANAGER FOR API PHARMA CO AT AHMEDABAD

A Quality Assurance (QA) Executive /Managaer in an Active Pharmaceutical Ingredient (API) plant in Ahmedabad manages compliance, documentation, and quality systems across chemical synthesis and bulk drug manufacturing units.
Key Responsibilities
Quality Management System (QMS): Maintain and monitor QMS elements, including Standard Operating Procedures (SOPs), change controls, deviations, and incident reports.

• CAPA & Investigations: Initiate, track, and close Corrective and Preventive Actions (CAPA) alongside Out of Specification (OOS) or Out of Trend (OOT) investigations.

Documentation & Review: Review and approve Master Batch Records (MBR), batch production records, validation protocols, and analytical test data.
Development Quality Assurance (DQA): Oversee lab notes, R&D scale-up studies, process validation, and technology transfer from R&D to pilot and commercial production.

• Audits & Compliance: Ensure adherence to cGMP (Current Good Manufacturing Practice), WHO, ICH, and USFDA guidelines; conduct internal audits and face regulatory/client inspections.
• Data Integrity & Line Clearance: Monitor shop-floor activities, line clearances, and ensure complete electronic and paper-based data integrity.

Eligibility & Requirements

• Education: B.Pharm, M.Pharm, M.Sc. in Organic Chemistry, or Pharmaceutical Chemistry.
• Experience: Typically 2 to 9+ years of hands-on experience in API or bulk drug manufacturing QA/IPQA.
• Key Skills:
• Strong knowledge of cGMP and regulatory compliance.
• Experience with root-cause analysis (CAPA, deviation handling).
• Familiarity with API process validation and equipment qualification (DQ/IQ/OQ/PQ).
• Good technical writing and communication skills.