Corporate Quality Control Officer

FDC Limited; Mumbai; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

FDC Limited is seeking an experienced Corporate Quality Control Officer in Mumbai for 8-15 years of Formulation R&D and finished dosage product development. The candidate will coordinate with Regulatory Affairs, QC, Corporate Quality Control, Formulation R&D, and third-party sites for data compilation, documentation review, stability data, deviations, and product development activities.

The role emphasizes rigorous data review, document accuracy, and timely submission, with cross-functional

Qualifications

• 8-15 years of Formulation R&D / Pharmaceutical Development experience.
• Experience in finished dosage formulation and drug product development.
• Review stability protocols, reports, change controls, and deviations; coordinate with RA, QC, CQC, and third-party sites.
• Strong documentation and data review skills.
• Formulation/finished dosage experience is mandatory; API experience alone is not sufficient.

Responsibilities

• Coordinate with RA, QC, and third-party sites for data compilation and submission.
• Review data for accuracy and completeness before RA submission.
• Review stability protocols and reports for new and existing products.
• Coordinate change controls and deviations with CQC.

Skills

Formulation R&D

Pharmaceutical Development

Stability Data Review

Regulatory Coordination

Documentation & Review

Quality Control

Cross-functional Coordination

CQC/RA Coordination

Education

M.Pharm / MSc / B.Pharm

Job description

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

Desired Profile

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