Corporate Quality Control Officer

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.
• Strong 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.