AGM Quality Assurance
- Datrax Services
- 2 Positions
- Mumbai
- 2 months ago
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Job Description
- USFDA regulatory audit exposure (must)
- Corporate or multi-plant QA experience
- Strong QMS, Deviations, CAPA expertise
- Formulation background only
- Ensure effective implementation of Quality Management Systems (QMS) across sites.
- Maintain compliance with USFDA, MHRA, WHO, TGA, and global regulatory bodies.
- Lead internal/external audits and support sites during regulatory inspections.
- Review & approve corporate SOPs, validation protocols, and product quality documents.
- Monitor deviations, OOS/OOT, change controls, and CAPA effectiveness.
- Drive root cause analysis and continuous improvement initiatives.
- Manage corporate risk management, change controls, and documentation systems.
- Collaborate with R&D, Manufacturing & RA for compliant product introductions.
- Conduct compliance reviews, audit summaries, and management presentations.
- Lead training & capability-building for site QA teams.
- Support vendor qualification, tech transfers & CMO site audits.
- Regulatory compliance score & audit outcomes
- Reduction in critical/major observations
- Timely closure of deviations & CAPAs
- QMS standardization across all sites
- Training completion & effectiveness
- Education: B.Pharm / M.Pharm / M.Sc
- Experience: 20+ years in QA (formulation), preferably corporate/multi-plant QA
- Strong knowledge of cGMP, ICH guidelines, QMS, validation & data integrity
- Hands-on experience with audits, investigations, CAPA, documentation & risk management
Hiring: DGM / AGM Corporate Quality Assurance (CQA)
Industry: Pharmaceutical (Formulation)
Department: Quality Assurance
Location: Andheri, Mumbai
Experience: 20+ Years
CTC: Up to 35 LPA
Mandatory Requirements:
About the Role:
We are hiring a seasoned Corporate Quality Assurance Leader to ensure uniform QA systems, global regulatory compliance, and continuous improvement across all manufacturing sites (Daman, Tarapur & Jammu). The role focuses on QMS harmonization, audit readiness, cGMP compliance, and oversight of corporate quality operations.
Key Responsibilities:
Key Performance Indicators:
Desired Candidate Profile:
Skills:
If you have the required experience and are open to exploring this opportunity, please reply with your updated CV.
Employement Category:
Employement Type: Full timeIndustry: Pharma / BiotechRole Category: Quality (QA-QC)Functional Area: Not SpecifiedRole/Responsibilies: AGM Quality AssuranceContact Details:
Company: Datrax ServicesLocation(s): Mumbai
Keyskills: cgmp qms corporate quality assurance capa ich quality cqa qa governance quality assurance
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