6 QC Officers – Method Validation

• Develop, optimize, and validate new analytical methods for raw materials and finished products.

• Execute method validation protocols including system suitability, precision, robustness, and reproducibility.

• Participate in method transfers between departments or external laboratories.

• Conduct method verifications to confirm accuracy and reproducibility in routine lab settings.

• Operate and maintain analytical instruments such as HPLC, UV-Vis spectrophotometers, FTIR, and dissolution testers.

• Ensure all method validation activities comply with cGMP and 21 CFR Part 11 regulations.

• Record, analyze, and review test data including chromatograms, calibration curves, and test reports.

• Collaborate with R&D, Regulatory Affairs, and QA teams on new product introductions and compliance initiatives.

• Participate in internal audits, investigations, and evaluations related to analytical methods.

• Prepare documentation for regulatory authorities such as NDA, WHO PQ, and EMA

Academic Qualifications:

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Biochemistry, Industrial Chemistry, or a related discipline from a recognized institution.

• Postgraduate qualifications or certifications in Quality Control or Laboratory Sciences are an added advantage.

Experience and Competencies:

• Minimum of 3 years’ experience in an analytical or QC role within the pharmaceutical or biopharmaceutical industry.

• Demonstrated experience in method development, validation, and troubleshooting of analytical techniques.

• Hands-on expertise with instrumentation such as HPLC, FTIR, UV-Vis, and dissolution testers.

• Solid understanding of ICH guidelines (Q2R2), ALCOA+ principles, and compendial methods (USP, BP, Ph. Eur).

• Knowledge of GMP, GLP, and regulatory standards from WHO PQ, NDA, and US FDA.

• Strong documentation, analytical thinking, and attention to detail.

• Ability to work independently and manage priorities in a fast-paced environment.