Quality control

Quality Control (QC) Analyst / Officer

Pharmaceutical API Manufacturing

Job Purpose

• Perform chemical, instrumental, and physical testing of raw materials, intermediates, in-process samples, finished APIs, and stability samples.
• Ensure compliance with approved specifications, pharmacopoeial requirements, GMP guidelines, and regulatory standards.

Key Responsibilities

• Analytical Testing
• Perform analysis of raw materials, intermediates, in-process samples, and finished APIs.
• Operate analytical instruments: HPLC, GC, UV-Visible spectrophotometer, FTIR, Karl Fischer, pH meter, and analytical balances.
• Perform tests: assay, related substances, residual solvents, water content, loss on drying, identification, and impurity profiling.
• Conduct wet chemistry tests: titration, limit tests, and volumetric analysis.
• Perform cleaning verification and validation sample analysis.
• Analyze stability samples according to approved stability protocols.
• Documentation and Data Integrity
• Prepare and maintain analytical worksheets, laboratory notebooks, and raw data.
• Review and maintain laboratory records, chromatograms, calculations, and instrument logs.
• Follow Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
• Ensure accurate recording, traceability, and timely reporting of analytical results.
• Prepare and review Certificates of Analysis (CoA).
• GMP and Regulatory Compliance
• Follow current Good Manufacturing Practices (cGMP) and applicable SOPs.
• Ensure compliance with applicable ICH guidelines, pharmacopoeial standards (IP, USP, EP), and regulatory requirements.
• Participate in internal audits, customer audits, and regulatory inspections.
• Follow laboratory safety procedures and proper handling of chemicals, reagents, and reference standards.
• OOS, OOT, and Laboratory Investigations
• Identify and report Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
• Participate in laboratory investigations and root cause analysis.
• Support CAPA implementation and effectiveness checks.
• Report deviations, atypical results, and instrument malfunctions.
• Follow approved investigation procedures.
• Instrument Calibration and Maintenance
• Perform routine instrument checks, calibration, and preventive maintenance as per SOPs.
• Maintain instrument usage logs and calibration records.
• Ensure instruments are qualified and suitable for intended use.
• Troubleshoot basic analytical instrument issues and coordinate with service engineers.
• Laboratory Management
• Prepare and standardize volumetric solutions, reagents, and mobile phases.
• Maintain reference standards, working standards, and reagent inventory.
• Ensure proper sample labeling, storage, and disposal.
• Maintain laboratory cleanliness, housekeeping, and chemical safety practices.

Educational Qualifications

• B.Sc. / M.Sc. in Chemistry, Analytical Chemistry, or a related discipline.
• B.Pharm / M.Pharm may be acceptable.

Experience Requirements

• Fresher: Basic analytical chemistry knowledge and willingness to learn GMP laboratory practices.
• Experienced: Typically 1–5 years of experience in QC analysis in API or pharmaceutical manufacturing.
• Hands-on experience with HPLC, GC, wet chemistry, and analytical documentation is preferred.

Required Skills

• Knowledge of API manufacturing processes and analytical testing.
• Practical experience with HPLC and GC.
• Understanding of cGMP, GLP, GDP, and ALCOA+ principles.
• Knowledge of OOS/OOT investigations, deviations, and CAPA.
• Good analytical, troubleshooting, and documentation skills.
• Ability to follow SOPs and meet testing timelines.
• Strong attention to detail and commitment to data integrity.