Candidate must have strong hands-on experience in QMS activities including Deviation, CAPA Change Contol, OOS handling. SOP documentation, and regulatory audit support in injectable / parenteral manufacturing.
Control manufacturing activities in the respective section to ensure activities carried out are as per requirement of cGMP & safety to meet the quality and manufacturing targets in time
Exposure of analysis for Finished Products, Stability Samples & Raw Materials. Having Knowledge of Analytical Method Validation, Verification & Method Transfer. Having skill for data interpretation, troubleshooting. Pharma knowledge of Solid orals & Quality process.
Openings in R&D, AR&D, Production, Labelling & Packing at Hetero Biopharma. Process development & scale-up. Tech transfer experience. DoE / QbD based process studies
Preference having exposure of regulatory inspections. Handling and controlling of daily production activities, improvement initiatives, interdepartmental coordination and manpower handling.
Responsible for the coordination of supportive equipment and process validation activities such as testing, calibration, scale-up, engineering and validation studies, and assurance that the necessary project documentation is complete, accurate and in compliance with cGMP regulations.