Sr. Executive-QC-Reviewer

Keka Inc.; Dharwad District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Keka Inc. seeks a Senior Executive - Quality Control to ensure data integrity and regulatory compliance of batch release records before final disposition. The role verifies RM, IP, FP documentation and GLP adherence, while updating specifications and MoA and supporting instrument calibration and audits.

The successful candidate will coordinate with QA and manufacturing teams to ensure inspection readiness and timely regulatory compliance across cGMP standards.

Qualifications

• Bachelor or Master degree in pharmacy or chemistry fields.
• Strong knowledge of cGMP, GLP and regulatory documentation.
• Experience in batch records review and analytical paperwork.

Responsibilities

• Review of RM documentation, CoA, specifications and results.
• Review IP and bulk product documentation and records.
• Review FP documentation, certificates and test results.
• Ensure GLP compliance and laboratory readiness.
• Prepare and revise specifications and MoA.
• Monitor pharmacopoeial and regulatory updates.
• Review calibration and instrument records (IQ/OQ/PQ).
• Support OOS/OOT investigations and lab investigations.
• Maintain document control and audit readiness.
• Support training and compliance activities.
• Assist during inspections and regulatory audits.
• Contribute to continuous improvement in QC processes.
• Collaborate with QA and manufacturing teams.

Skills

Documentation Review

Quality Assurance

Regulatory Compliance

Education

B.Pharm

M.Pharm

B.Sc

M.Sc in Chemistry

Tools

LIMS

Document control systems

Job description

A Senior Executive - Quality Control (QC) Review is required to ensure the highest standards of data integrity, compliance with current Good Manufacturing Practices (cGMP) & Good Laboratory Practices, and the thorough review and verification of analytical and batch documentation. The role is critical for ensuring the accuracy, completeness, and regulatory compliance of batch release records prior to the final disposition and release of products to the market.

• 1. Review of Raw Material (RM) Documentation like Raw Material test reports, Certificates of Analysis (CoA), specifications and analytical results
• 2. Review of In-Process (IP) & Bulk Product Documentation like In-Process test reports and analytical records
• 3. Finished Product (FP) Documentation Review like Finished Product analytical reports, test results and Certificates of Analysis
• 4. GLP Documentation & Laboratory Compliance
• 5. Specification Preparation & Revision
• 6. Method of Analysis (MoA) Preparation & Review
• 7. Pharmacopoeial & Regulatory Update
• 8. Calibration Documentation Review
• 9. Instrument & Equipment Documentation like IQ/OQ/PQ, calibration and preventive maintenance records
• 10. OOS/OOT & Laboratory Investigation Support
• 11. Document Control
• 12. Audit & Inspection Readiness
• 13. Training & Compliance

Qualifications & Experience Required:

Degree: B.Pharm, M.Pharm, B.Sc, or M.Sc. in Chemistry, Organic Chemistry,