Detail-oriented Pharmaceutical Quality Control Professional with experience in chemical and instrumental analysis of Raw material, In-process sample, and finished products. And Reviewer with solid expertise in review of analytical data, laboratory documentation and compliance with GMP, GLP, and regulatory guidelines.

Review of analytical worksheets, Raw data, chromatograms, and laboratory notebooks.

Preparation and Verification of Certification of Analysis (COA)

Management of Stability, FP and GLP system for receipts, and Testing

Review of STP, SOP, Validation & Investigation Protocols

Evaluation of OOS, OOT, Deviation & Investigation,

In case of any lab deviation with respect to procedure. It is investigated and documented.

Checked instrument usage logs, Calibration records, and maintenance logs.

Ensured data integrity compliance (ALCOA+)

Review Stability study data and reports and summary.

Operated and troubleshot HPLC, GC, UV, FTIR, Dissolution Apparatus

Ensure high precision, accuracy, and data integrity in all laboratory testing and documentation processes.

Trained and guided junior analysts

Ensure compliance with GMP, GLP, WHO, and ICH guidelines.

📌 Quality Control Executive (Gangtok)
🏢 Alkem Laboratories
📍 Gangtok