16 Oct
|
AMN LIFE SCIENCE
|
Mumbai
16 Oct
AMN LIFE SCIENCE
Mumbai
Job Title: Manager - Corporate Quality Assurance (CQA)
Company: AMN Life Science
Location: Mumbai, Maharashtra
Experience: 10 - 12 Years
Qualification: B.Pharm / M.Pharm / M.Sc. or relevant scientific qualification
Job Summary
We are looking for an experienced Manager – Corporate Quality Assurance (CQA) to oversee corporate quality operations, QMS documentation, vendor qualification and quality coordination across the Head Office and manufacturing sites.
Key Responsibilities
- Manage QMS activities, SOP preparation, review, approval and implementation.
- Review deviations, coordinate investigations and monitor CAPA closure across manufacturing sites.
- Coordinate site and vendor audits, vendor qualification and documentation compliance.
- Review purchase orders against approved product registrations and specifications.
- Manage Product Data Lists (PDLs), COAs, artwork approvals and product-related documentation.
- Coordinate with Regulatory Affairs, R&D;, Sales, Procurement and manufacturing sites.
- Manage ERP-related item codes, BOMs and product specifications.
- Monitor manufacturing licences, certificates and regulatory documentation.
- Maintain CQA trackers, MIS reports and ensure timely closure of quality-related actions.
Required Skills & Experience
- 10 - 12 years of experience in pharmaceutical Quality Assurance, preferably in Corporate QA or CMO management.
- Knowledge of pharmaceutical QMS, GMP, deviations, CAPA, audits and vendor qualification.
- Experience with pharmaceutical formulations, product documentation and regulatory requirements.
- Familiarity with ERP systems, document control and cross-functional coordination.
- Robust communication, analytical and documentation skills.
Interested candidates may apply with their updated CV.
Benefits
- Health insurance
- Provident Fund
Work Location: In person
📌 Quality Assurance Manager (Mumbai)
🏢 AMN LIFE SCIENCE
📍 Mumbai