Job Description

Position: QC Analyst Department: Quality Control Designation: Officer / Sr. Officer Education Qualification: M.Sc. in Biotechnology or Chemistry or Microbiology Total Years of Experience: 2 - 4 Years Job Role: QC Analyst Responsibilities:

• Ensure compliance to cGMP and safety standards in the Quality Control Lab.
• Preparations & usage of microbiological media and Reagents etc. and ensure always availability of prepared/qualified media for routine usage in Lab.
• Conduct Calibration of laboratory equipment/instruments.
• Maintain laboratory equipment, inventory and supplies.
• Ensure integrity, accuracy and adequacy of the analysis performed.
• Maintain documents issuance, retrieval and arrangement with complete traceability. Ensure compliance to cGMP and safety standards in Central Quality Control, Stability, Microbiology Lab. and Packaging Lab.
• To ensure, execute and facilitate daily GLP and Instrumentation activities pertaining to Central Quality Control, Stability, Microbiology Lab. and Packaging Lab.
• Responsible for calibration (In-House and External Calibration) of Analytical instrument in Central Quality Control, Stability, Micro. Lab. and Packaging Material Lab.
• Management of reference standard, primary standard, lab chemicals, lab stationary etc. and its associated activities.
• To ensure timely preparation and standardization of lab reagents and volumetric Solutions in Central Quality Control, Stability, Microbiology Lab. and Packaging Material Lab.
• To ensure availability of lab chemicals, lab stationaries and other lab related items in Central Quality Control, Stability, Microbiology Lab. and Packaging Lab.
• Preparation and review of Schedule/Planners (In-House Calibration, External Calibration, PPV-PTS and PPV-SPR).
• Preparation and maintenance of Calibration Standards/ Primary Standards as and when required.
• Ensure timely completion of Periodic calibration of laboratory instrument and its associated activities.
• Coordinate with concern stake holders and vendors for timely completion to GLP and instrumentation related activities.
• Document analytical data and calculate the results.
• Ensure integrity, accuracy and adequacy of the analysis/activity to be performed.
• Ensure accuracy of document and maintain neat/concise/organized analytical/activity data.
• Perform other activity as and when required.
• Ensure Compliance to cGMP requirements and laboratory procedures.
• Co-ordination with External vendor for calibration/Preventive maintenance activity whenever required.
• Responsible for ensuring cGMP and GDP compliance during routine work.
• Responsible for ensuring integrity, accuracy and adequacy of the activity performed.
• Accountable for all activities related to instruments, GLP, Qualification and Documentation.
• To ensure contamination controls implemented and followed at site as per Contamination Control Strategy (CCS) and respective procedures.

Sun Pharmaceutical Industries