Quality Control Reviewer

Assistant Manager – Quality Control Reviewer (Pharmaceutical Formulations) Department: Quality Control (QC) Designation: Assistant Manager – QC Reviewer Experience: 8–10 Years Industry: Pharmaceutical Formulations Job Summary We are seeking an experienced and detail-oriented Quality Control Reviewer to oversee the review and approval of analytical data generated in the Quality Control Laboratory for pharmaceutical formulation products. The incumbent will ensure compliance with cGMP, regulatory requirements, data integrity principles, and internal quality standards while supporting timely batch release activities. Roles & Responsibilities Analytical Data Review Review and verify analytical raw data, calculations, chromatograms, worksheets, and laboratory records generated for finished products, in-process samples, raw materials, packing materials, stability samples, and cleaning validation samples.

Ensure analytical testing is performed in accordance with approved specifications, STPs, SOPs, and pharmacopoeial requirements. Review laboratory documentation for completeness, accuracy, and compliance prior to approval. Batch Release Support Review Certificates of Analysis (CoA) and analytical reports for batch disposition.

Coordinate with QA for timely release of raw materials, packing materials, intermediates, and finished products. Ensure adherence to batch release timelines. Instrument & Laboratory Compliance Review audit trails, electronic data, and system suitability results generated from laboratory instruments.

Verify compliance with data integrity requirements (ALCOA+ principles). Ensure laboratory activities comply with cGMP and applicable regulatory guidelines. OOS/OOT/Deviation Investigations Participate in investigations related to: Out of Specification (OOS) results Out of Trend (OOT) results Laboratory deviations Incidents and atypical observations Review investigation reports and recommend appropriate corrective and preventive actions (CAPA).

Stability Program Review Review stability testing data and reports. Ensure timely completion of stability studies as per approved protocols. Support evaluation of stability trends and reporting.

Documentation & Compliance Review and approve: Analytical worksheets Instrument usage logbooks Laboratory notebooks Standard Test Procedures (STPs) Specifications SOPs and revisions Protocols and reports Ensure proper archival and retrieval of laboratory records. Audit & Regulatory Support Participate in internal, customer, and regulatory audits. Address audit observations related to QC review activities.

Support inspections by regulatory authorities including USFDA, MHRA, WHO, EU, TGA, and other agencies. Team Management & Training Provide guidance and technical support to QC analysts and reviewers. Conduct training on GMP, GDP, data integrity, analytical procedures, and SOP compliance.

Review team performance and support capability development initiatives. Cross-Functional Coordination Coordinate effectively with: Quality Assurance (QA) Production Warehouse Regulatory Affairs Stability Team Microbiology Laboratory Ensure smooth execution of quality-related activities and timely closure of review observations. Required Skills Strong knowledge of pharmaceutical formulation quality control practices.

Thorough understanding of: cGMP GDP Data Integrity (ALCOA+) OOS/OOT investigations Stability studies Pharmacopoeial requirements (IP, USP, BP, EP) Regulatory expectations and laboratory compliance. Excellent analytical review and documentation skills. Strong leadership, decision-making, and problem-solving abilities.

Educational Qualification M.Sc. (Chemistry / Analytical Chemistry) or B.Pharm / M.Pharm Preferred Candidate Profile 8–10 years of experience in Quality Control within pharmaceutical formulation manufacturing. Hands-on experience in analytical data review and batch release support. Experience working in USFDA, MHRA, WHO, EU, or other regulated manufacturing environments.