Oversee daily QC laboratory operations, ensuring compliance with cGMP, FDA, and other regulatory requirements. Validate, and implement analytical methods, including HPLC and plate-based assays as well as General assays. Ensure accurate and timely testing of raw materials, packaging materials, in-process samples, and finished products.
Deep understanding of Pharma GMP testing industry and the testing requirements of Method Development and Validation, Trace analysis Nitrosamine, Elemental, Genotoxic, Related substances E&L Testing & Packaging testing.
Support Formulation R&D in arranging the materials for development, optimization, confirmatory and exhibit batches which are under development in Hyderabad surround locations. API samples, Impurities, Working standards support for Formulation development stage.
M.Sc. / M.Pharm, Technically competent on analytical method development and Validation of complex products like liposomes, transdermal, long acting injectable, suspensions, Nano particles, Microspheres, topicals and peptides. Responsible for developing, establishing, and validating analytical testing methodologies, transfer; ensure all analytical testing activities are in compliance with applicable regulatory guidance.
B.Pharma / M.Pharma / M.Sc.; Experience in Quality Assurance QMS, AQA, Process Validation, IPQA, RACoordinator, Training, Computer System Validation. Macleods Pharmaceuticals Ltd. is one of the fastest growing pharmaceutical company.
Formulation development in solid orals tablets, Capsules, Pellets, Soft gels. Should have experience in extended release, delayed release, multiparticulate.