Job Description – Corporate Quality Assurance (CQA) Executive / Assistant Manager Position (HO Mumbai)
Corporate Quality Assurance (CQA) Sr. Executive / Assistant Manager
Experience
8-10 Years
Industry
Pharmaceutical Manufacturing
Department
Corporate Quality Assurance (CQA)
Reporting To
Head – Corporate Quality Assurance
Job Summary
We are looking for an experienced and dynamic professional for the Corporate Quality Assurance department with 8–10 years of experience in pharmaceutical manufacturing. The candidate should have hands-on experience in Corporate QA activities, regulatory coordination, FDA office visits, COPP applications, Product Permission (PP) registration activities, vendor management, Artwork Approval, compliance monitoring, and quality system implementation across manufacturing sites.
The candidate should possess strong knowledge of GMP, regulatory requirements, documentation practices, audit management, and coordination with regulatory authorities.
Key Responsibilities Corporate Quality Assurance Activities
- Implementation and monitoring of Corporate Quality Systems across manufacturing sites.
- Review and approval of SOPs, specifications, protocols, reports, formats, and quality documents.
- Handling Change Control, Deviations, CAPA, Incidents, Risk Assessments, and Market Complaints.
- Monitoring GMP compliance and data integrity practices.
- Preparation and review of Annual Product Quality Review (APQR/PQR).
- Coordination for qualification and validation activities.
- Review and monitoring of training compliance across sites.
- Monitoring of audit compliance and closure of CAPA within timelines.
- Preparation and review of quality metrics and management review data.
Regulatory & FDA Coordination
- Coordination with State FDA and other regulatory authorities.
- Visiting FDA offices for submission, follow-up, and approval activities.
- Handling Product Permission (PP) application and registration activities.
- Coordination for COPP (Certificate of Pharmaceutical Product) applications and documentation.
- Preparation and submission of regulatory documents as per authority requirements.
- Follow-up for product approvals, manufacturing permissions, and related regulatory activities.
- Coordination for plant layout approvals and regulatory compliance documentation.
Audit Management
- Conducting internal audits, vendor audits, and corporate audits.
- Preparation of audit reports and CAPA follow-up.
- Vendor qualification and vendor performance monitoring.
- Coordination during regulatory inspections and customer audits.
- Ensuring implementation of audit observations across sites.
Artwork & Packaging Material Review
- Review and approval of packaging artwork materials such as carton, foil, labels, inserts, and shipper artworks.
- Verification of artwork details including product name, composition, batch coding area, manufacturing license number, warning statements, storage conditions, barcode, and regulatory text.
- Coordination with Regulatory Affairs, Packaging Development, and Production departments for artwork approval.
- Ensuring artwork compliance with current regulatory requirements and approved product permissions.
- Maintaining artwork control records and version management.
SOP Review activity :-
- SOP need to review after preparation of SOP.
Required Skills
- Strong knowledge of GMP, GLP, GDP, and regulatory guidelines.
- Knowledge of FDA regulations and pharmaceutical documentation practices.
- Good communication and coordination skills.
- Strong documentation and investigation skills.
- Ability to handle multiple site coordination activities.
- Proficiency in MS Office and quality documentation systems.
- Good understanding of Data Integrity and Quality Risk Management.
Qualification
- B.Pharm / M.Pharm / B.Sc / M.Sc or equivalent qualification in Pharmacy or Life Sciences.
Preferred Experience
- Experience in formulation pharmaceutical manufacturing company.
- Exposure to regulatory audits and FDA interactions.
- Experience in COPP, PP registration, and regulatory submission activities.
- Experience in Corporate QA and multi-site quality coordination.
Key Competencies
- Leadership and team coordination
- Regulatory compliance focus
- Problem-solving ability
- Attention to detail
- Time management
- Integrity and accountability
Pay: ₹500,000.00 - ₹700,000.00 per year
Benefits:
- Health insurance
- Life insurance
- Provident Fund
Work Location: In person
