: Quality Control (QC) API Pharmaceutical Industry

Job Title: Quality Control (QC) Analyst / Officer Active Pharmaceutical Ingredients (API)

Department: Quality Control / Quality Assurance

Industry: Pharmaceutical API Manufacturing

Reports To: QC Manager / Quality Control Head

1. Job Purpose To perform chemical, instrumental, and physical testing of raw materials, intermediates, in-process samples, finished APIs, and stability samples to ensure compliance with approved specifications, pharmacopoeial requirements, GMP guidelines, and regulatory standards.

2. Key Responsibilities and Duties

A. Analytical Testing

- Perform analysis of raw materials, intermediates, in-process samples, and finished APIs.
- Operate analytical instruments such as HPLC, GC, UV-Visible spectrophotometer, FTIR, Karl Fischer, pH meter, and analytical balances.
- Perform tests such as assay, related substances, residual solvents, water content, loss on drying, identification, and impurity profiling.
- Conduct wet chemistry tests, including titration, limit tests, and volumetric analysis.
- Perform cleaning verification and validation sample analysis, as applicable.
- Analyze stability samples according to approved stability protocols.

B. 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 Positive 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), where authorized.

C. 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.

D. 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 to the supervisor.
- Follow approved investigation procedures without unauthorized retesting or resampling.

E. 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 when required.

F. 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.

3. Educational Qualifications

- B.Sc. / M.Sc. in Chemistry, Analytical Chemistry, or a related discipline.
- B.Pharm / M.Pharm may be acceptable, depending on the company's requirements.

4. 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, depending on the position.
- Hands-on experience with HPLC, GC, wet chemistry, and analytical documentation is preferred.

5. 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.

📌 Quality control (Hyderabad)
🏢 Aurore Life Sciences
📍 Hyderabad