Quality professionals with hands-on experience in API manufacturing environments, who can drive compliance, strengthen quality systems, and support audit readiness across regulated markets. As an Assistant Manager – QA, you will play a key role in ensuring that all manufacturing processes, systems, and documentation consistently meet global regulatory and quality standards.

You will work closely with Production, QC, and Regulatory teams to maintain a robust Quality Management System (QMS) while supporting inspections and driving continuous improvement initiatives across the plant.

Responsibilities

Support and manage Quality Assurance activities across API manufacturing operations, ensuring adherence to defined quality standardsEnsure compliance with cGMP, ICH Q7 guidelines, and global regulatory requirements across all processes and systemsHandle and review Deviations, CAPA, Change Control, and OOS/OOT investigations, ensuring timely closure and effectivenessMaintain and continuously improve the Quality Management System (QMS), ensuring robust implementation across functions

Drive documentation control practices, including SOPs, BMR/BPR review, and management of quality recordsSupport regulatory audits and inspections (USFDA, EMA, WHO, MHRA), ensuring a state of audit readiness at all times

Perform line clearance, batch release support, and in-process quality checks to ensure product quality and compliance

We’re Looking For

B.Pharm / M.Sc / M.Pharm (preferred)

7 –10  years of experience in Quality Assurance – API / Bulk Drug manufacturing

Strong understanding of ICH Q7, cGMP, and regulatory compliance frameworks

Hands-on experience in QMS processes and audit handling

Exposure to regulated markets (US / EU) preferred