19 Oct
|
AMN Life Science
|
Mumbai
19 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.
Advantages
Health insurance
Provident Fund
Work Location: In person
📌 Quality Assurance Manager Mumbai
🏢 AMN Life Science
📍 Mumbai