We are looking for an experienced Corporate Quality Control Officer with 8-15 years of relevant experience in pharmaceutical formulation and finished dosage products. The candidate will be responsible for coordination with RA, QC, Corporate Quality Control, Formulation R&D;, and third-party sites for technical data compilation, document review, stability documentation, change controls, deviations, and product development activities.

Key Responsibilities:

- Compile queries received from the Regulatory Affairs (RA) Department and coordinate with site QC teams for timely data compilation and submission.
- Review data received from sites for accuracy, completeness, and correctness against raw data before submission to the RA Department.
- Review stability protocols and stability reports for new drug products and existing products prepared by Formulation R&D.;
- Coordinate with the Corporate Quality Control (CQC) Department regarding change controls and deviations.
- Review relevant documents and recommend necessary corrections, additions, and deletions to ensure accuracy and completeness.
- Review joint analysis reports and other technical documents related to P-to-P (Product-to-Product) products.
- Review documentation related to new products being developed at third-party sites.




- Coordinate with relevant cross-functional teams regarding technical observations and documentation.
- Discuss reviewed documents and technical points with the CQC Head and coordinate for final approval.
- Ensure timely completion and submission of required technical and regulatory documentation.

Required Experience & Skills:

- 8-15 years of relevant experience in Formulation R&D; / Pharmaceutical Development.
- Robust experience in finished dosage formulation and drug product development.
- Hands-on experience in reviewing stability protocols, stability reports, technical reports, change controls, and deviations.
- Experience coordinating with RA, QC, CQC, and third-party manufacturing/development sites.
- Strong understanding of pharmaceutical documentation and data review.
- Good analytical, communication, coordination, and documentation skills.
- Formulation/finished dosage experience is mandatory; API experience alone will not be considered.

Qualification:

- M.Sc. / M.Pharm / B.Pharm

Job Location: Andheri, Mumbai

Candidates from across Mumbai can apply.

Desired Profile:

Candidates currently working in Formulation R&D;, Pharmaceutical Development, Product Development, or formulation-related technical documentation/review roles will be preferred.

📌 Corporate Quality Control Officer (Mumbai)
🏢 FDC
📍 Mumbai