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Assistant Manager - Quality Assurance / Reliance Rasayan - API - WHO-GMP Facility - job post

RELIANCE RASAYAN PVT LTD
Naroda Gidc, Ahmedabad, Gujarat
₹45,000 - ₹50,000 a month

Job details

Pay

  • ₹45,000 - ₹50,000 a month

Job type

  • Full-time

Location

Naroda Gidc, Ahmedabad, Gujarat

Full job description

Job description

Role & responsibilities

  • Strong knowledge of 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 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 (WHO/GMP, preferred) (USFDA/EMA)
  • Experience in validation, APR/PQR, stability studies, and technology transfer activities
  • Strong understanding of data integrity and risk assessment practices

Education

UG: B.Pharma in Pharmaceutical, Pharmaceutical Chemistry

PG: M.Pharma in Pharmacy, MS/M.Sc(Science) in Chemistry

Job Type: Full-time

Pay: ₹45,000.00 - ₹50,000.00 per month

Work Location: In person

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