Position
Senior Officer – Quality Control (QC)
Department
Quality Control
Industry
Pharmaceutical Formulation Manufacturing
Reporting To
QC Manager / Head – Quality Control
Job Purpose
The Senior Officer – Quality Control is responsible for ensuring the testing, analysis, documentation, and release-related quality control activities of raw materials, in-process samples, finished products, stability samples, and other laboratory samples in compliance with approved specifications, SOPs, GMP, and regulatory requirements.
Key Responsibilities1. Sampling and Analysis
- Perform and supervise analysis of raw materials, packing materials, in-process samples, finished products, and stability samples.
- Conduct chemical and instrumental analysis as per approved specifications, STPs, and SOPs.
- Review analytical data and ensure accuracy, completeness, and compliance.
2. Instrument Handling
- Operate and ensure proper handling of laboratory instruments such as:
- HPLC
- UV-Visible Spectrophotometer
- FTIR
- Dissolution Apparatus
- Disintegration Test Apparatus
- pH Meter
- Analytical Balance
- Other QC laboratory equipment
- Ensure calibration, verification, and maintenance activities are performed as per the approved schedule.
3. Documentation
- Review and maintain analytical worksheets, logbooks, instrument usage records, and laboratory documentation.
- Ensure compliance with GDP, GMP, and data integrity requirements.
- Review COAs, analytical reports, and test results before submission to the QC Manager.
4. OOS / OOT / Deviations
- Participate in the investigation of OOS, OOT, deviations, incidents, and laboratory errors.
- Support implementation of CAPA and effectiveness checks.
- Ensure proper documentation and timely closure of investigations.
5. Stability and Method Activities
- Perform and review stability sample analysis as per the stability protocol.
- Assist in analytical method verification, validation, and transfer activities when required.
6. Team Supervision
- Guide and supervise QC Officers, Junior Officers, and Analysts.
- Ensure proper allocation of daily laboratory activities.
- Provide training to team members on SOPs, analytical procedures, GMP, and laboratory practices.
7. Compliance and Audit Support
- Ensure the QC laboratory complies with approved SOPs, GMP, GLP, and regulatory requirements.
- Support internal audits, customer audits, and regulatory inspections.
- Ensure laboratory readiness and timely completion of audit observations.
Educational Qualification
B.Pharm / M.Pharm / B.Sc. / M.Sc. in Chemistry or a relevant discipline
Experience
5–8 years of experience in the Quality Control Department of a pharmaceutical formulation manufacturing plant.
Required Skills
- Strong knowledge of GMP, GLP, GDP, and Data Integrity.
- Hands-on experience with analytical instruments, especially HPLC and UV.
- Knowledge of pharmaceutical formulation testing and documentation.
- Experience in handling investigations, OOS/OOT, deviations, and CAPA.
- Good leadership, communication, and team management skills.
- Ability to review analytical data and laboratory documentation.
Key Performance Indicators (KPIs)
- Timely completion of testing and analysis.
- Accuracy and compliance of analytical documentation.
- Timely closure of OOS/OOT, deviations, and CAPA.
- Instrument calibration and maintenance compliance.
- Audit readiness and regulatory compliance.
- Effective supervision and training of QC team members.
Work Location: In person
