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 Positive 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:
Solid 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).
Valuable technical writing and communication skills.

📌 Executive Manager For Qa Quality Assurance In Api Pharma Ahmedabad Dholka
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📍 Dholka