Manager / Sr.Exe. Corporate Quality Assurance(CQA) For Pharma Co. Pune

Role & responsibilities :

CORPORATE QUAKLITY ASSURANCE

1. Specification Preparation & Documentation

• Develop and maintain specifications for raw materials (APIs, excipients) and packing materials.
• Ensure specifications comply with pharmacopeial standards and in-house quality standards.
• Review and update specifications based on regulatory updates, stability studies, and supplier changes.
• Coordinate with purchase, packaging development, QC, and regulatory teams for finalizing specifications.

2. Raw Material (RM) Specification Management

• Maintain records of Material Safety Data Sheets (MSDS) and Certificates of Analysis (COA) from suppliers.

3. Packing Material (PM) Specification Management

• Develop specifications for primary, secondary, and tertiary packaging materials.
• Ensure packing materials comply with stability, compatibility, and regulatory requirements.
• Conduct compatibility studies to assess interaction with drug formulations.
• Define parameters like GSM, burst strength, WVTR, dimensions, artwork compliance.

4. Regulatory & Compliance Assurance

• Ensure regulatory compliance with global standards (USFDA, WHO-GMP)
• Assist in audit preparation and responses related to material specifications.
• Ensure proper documentation and version control of Master Specification Files.

5. Vendor & Cross-functional Coordination

• Collaborate with vendors for RM & PM specification approvals.
• Work with Quality Control (QC), Quality Assurance, and Procurement to resolve material specification issues.
• Participate in vendor qualification, site audits, and material evaluation.

6. Acting as SPOC Between Factory & Corporate

• Serve as the primary liaison between the corporate QA team and the factory team regarding RM & PM specifications.
• Ensure smooth communication and implementation of corporate quality standards at the factory level.
• Address and resolve factory concerns related to RM & PM specifications in coordination with corporate QA.

7.Addressing Factory Concerns & Quality Compliance

• Resolve factory-level issues related to raw and packing materials by aligning corporate directives.
• Support factory teams in implementing quality control procedures for RM & PM.
• Ensure material handling, storage, and testing compliance at factory sites.
• Coordinate and support regulatory inspections and customer audits at manufacturing sites.
• Ensure timely CAPA (Corrective and Preventive Action) implementation post-audits.
• Maintain audit readiness across manufacturing and distribution facilities
• Design and approve the corporate documents to meet highest levels of quality standards.
• Conduct vendor audits and qualification for raw materials, packing materials, and contract manufacturers (P2P).
• Collaborate with the Procurement Department to ensure suppliers meet the required quality standards.
• Establish quality agreements with vendors and monitor compliance.
• specifications in coordination with corporate QA.

Knowledge Required

1. 8 10years of relevant experience in Pharma industry.

2. Strong knowledge of pharmacopeia standards (IP, USP, BP, EP).

3. Expertise in specification writing and document management.

4. Knowledge of analytical techniques (HPLC, GC, UV, Titration, etc.).

5. Familiarity with ICH Q3C, Q6A, GMP, and GDP guidelines.

6. Knowledge of Specification Preparation of Raw Material / Packing Material / Finished Product

7. Knowledge of Pharmacopeia Monograph - Indian Pharmacopoeia / British Pharmacopoeia / United States Pharmacopoeia

8. Must have knowledge of General Testing Procedures related to Raw Material / Packing Material / Finished Product testing.

9. Must have proficiency in computer operating ( Specially MS Word )

10. Able to communicate effectively with Factory Site and Purchase / RA Dept..

11. Shall be able to communicate with Purchase Dept. related to P2P products.

12. Ensure cross-functional teams (Production, Purchase, Regulatory Affairs) are aligned with quality expectations.

13. Should be able to travel to third party site/s.

14. Should possess good verbal and written communication skills.

15. Exposure to regulatory agencies audits such as Schedule - M, USFDA, MHRA, WHO, ISO etc.

Please note: Female candidate is preferred provided she should be able to travel outstation once in week on monthly basis.