Quality Control

Key Responsibilities

• Sampling & sample management: Collect and prepare samples of raw materials, in-process intermediates, and finished API products as per approved sampling plans and Standard Operating Procedures (SOPs).

• Analytical testing: Perform routine and non-routine chemical and physical analysis using instruments such as HPLC, GC, UV Spectrophotometer, Karl Fischer Titrator, Dissolution Apparatus, and LoD

• Microbiology support: Carry out microbiological testing in coordination with the Microbiology laboratory including Water sampling, testing, product microbiological tests sterility, and environmental monitoring as applicable.

• GMP documentation: Record all analytical data accurately in laboratory notebooks and electronic LIMS in accordance with ALCOA+ principles, GMP documentation standards, and data integrity requirements.

• Instrument qualification: Perform routine calibration, qualification checks, and preventive maintenance of QC instruments; maintain calibration logs and instrument usage records.

• OOS / OOT investigation: Identify and immediately escalate Out-of-Specification (OOS) and Outof-Trend (OOT) results to senior analysts or the QC Supervisor; assist in root cause investigation under guidance.

• Stability studies: Assist in stability testing programs; place and retrieve stability samples from ICH stability chambers; perform scheduled analysis per stability protocols

. • Certificates of analysis: Prepare Certificates of Analysis (CoA) and analytical reports for raw materials and finished APIs after review and approval by senior QC personnel.

• Regulatory compliance: Ensure strict adherence to cGMP, safety regulations, and laboratory housekeeping standards at all times; actively participate in internal quality audits and regulatory inspections.

• R&D support: Support R&D activities includ