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:
- Robust 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.

📌 Executive -Manager For QA (Quality Assurance ) IN API Pharma Ahmedabad
🏢 Success Vibrant Hr u0026 Pr Solutions
📍 Ahmedabad