Deputy Manager - Quality Assurance

Job Description

Role & responsibilities

Strong knowledge of peptide/API manufacturing processes.
Experience in batch release management, ensuring compliance with regulatory and internal requirements.
Review of executed batch records, including audit trail review for data integrity compliance.
Preparation and review of Annual Product Reviews (APR) in line with regulatory expectations.
Preparation and review of Process Validation protocols and reports.
Review of technology transfer documents and data for completeness and compliance.
Initiation, review, and management of QMS elements such as Deviations, Change Controls, OOS, OOT, and CAPA.
Oversight of dispatch activities and line clearance to ensure compliance with GMP requirements.
Experience in cleaning validation, including protocol and report review.
Conducting internal audits and ensuring timely closure of audit observations

Preferred candidate profile

Strong experience in API/peptide manufacturing within a GMP-regulated environment
Hands-on experience in batch release, BMR/BPR review, and QMS management (Deviation, OOS, CAPA, Change Control)
Proven exposure to regulatory and customer audits (USFDA/EMA preferred)
Experience in validation, APR/PQR, stability studies, and technology transfer activities
Working knowledge of LMS, Ensur, and TrackWise software
Strong understanding of data integrity and risk assessment practices