Job highlights

- Review and maintain product-wise documentation,including Certificates of Analysis (COA),master formulas,product specifications,Methods of Analysis (MOA),testing requirements,stability data,and applicable licences.

Job Summary To ensure that pharmaceutical products manufactured through third-party manufacturers comply with applicable quality standards, regulatory requirements, approved product specifications, and internal quality policies. The role involves vendor qualification, product documentation, packaging artwork approval, quality assurance, regulatory compliance, and coordination with manufacturers to ensure timely product launches and consistent product quality.

Designation

QA Executive / Assistant Manager / Manager

Key Roles and Responsibilities

A. Vendor Qualification and Quality Audits

- Evaluate and qualify third-party manufacturers based on manufacturing capabilities, quality systems, regulatory compliance, and valid licences.
- Collect, verify, and maintain manufacturing licences, GMP certificates, product permissions, and other applicable regulatory documents.
- Coordinate vendor audits and monitor corrective and preventive actions (CAPA).
- Maintain an updated database of approved manufacturers and vendors.

B. Product Documentation and Regulatory Compliance

- Review and maintain product-wise documentation, including Certificates of Analysis (COA), master formulas, product specifications, Methods of Analysis (MOA), testing requirements, stability data, and applicable licences.
- Ensure all mandatory documentation and approvals are completed before purchase order execution, production, and product launch, as applicable.
- Verify product classification, including prescription (Rx) and over-the-counter (OTC) status,



in coordination with Regulatory Affairs.
- Ensure compliance with applicable provisions of the Drugs and Cosmetics Act and Rules, pharmaceutical labelling requirements, and other relevant regulations.

C. Packaging Artwork Approval

- Review packaging artwork for mono cartons, labels, blister foils, bottle labels, shipper boxes, and other packaging materials.
- Verify composition, strength, dosage form, manufacturing details, batch information, MRP, expiry date, warnings, and other mandatory declarations.
- Ensure compliance with approved brand guidelines, logo placement, brand spelling, product name visibility, and packaging specifications.
- Coordinate with manufacturers, designers, and internal teams to resolve artwork discrepancies before approval.
- Maintain approved artwork versions and corresponding CDR/PDF files.

D. Product Quality and Specification Approval

- Review product specifications and testing requirements before product approval.
- Coordinate sample evaluation and testing with manufacturers and approved testing laboratories, wherever required.
- Verify compliance with approved specifications and applicable pharmacopoeial or other recognised quality standards.
- Review COAs and ensure the availability of required quality documents before dispatch approval.
- Investigate quality failures, deviations, out-of-specification results, and recurring product complaints.

E. Production and Dispatch Quality Control

- Monitor manufacturing activities to ensure compliance with approved specifications, packaging artwork, and quality requirements.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Quality Assurance (QA) Professional (Baruipur)
🏢 Estalvis Advisors
📍 Baruipur