Quality Control Associate -Bioassay

Cell based testing for Batch testing _commercial and Stability batches

• Performing a range of cell-based assays , Test the samples as assigned & release the data as per defined timelines – Commercial, Stability & Campaign batches
• Ensure that no executional errors occurred against set procedures
• Ensure that required reagents, buffers are prepared according to the testing plan and equipment’s are available for analysis in order to ensure smooth completion of analysis within turnaround time.
• Document the activities Contemporaneously
• Understand the Good Documentation Practices and compliance to the expectations
• Self check of the document after completion of the analysis whether the document is is error free and all entries given correctly; Correct it prior to the submission if found any error in order to ensure compliance to the good documentation practices.

Support investigations

• Inform the supervisor on risk actions like SSF, OOS,OOT & ATI Immediately and support investigation process with required data and analysis;
• Understand & adhere to the QMS systems and closure timelines
• Support and execute Laboratory investigations and discrepancy closures;
• Support in audits as defined role in order to ensure the quality of failure investigation is met the defined standards

Lab equipment and GLP adherence

• Ensure the lab cleanliness, Sample storage, Chemical labeling, removal of expired material, usage of calibrated equipment, usage of authorized/QA issued documents, Analyst qualifications, document revisions as assigned, training compliance and adherence to quality standards/system
• Training new joinees on analytical techniques in order to ensure the compliance of GLP
• Calibrate and maintain the assigned equipment as per defined frequency
• Qualify the equipment (IQ/OQ/PQ) in a timely manner, with assistance from vendor, in order to support laboratory efficiency
• Rectify problems related to the instruments (like air bubble trapping,flow problem,noise problem, changing of frit.) ; In case of unknown problems, do RCA along with investigator & rectify it. In order to ensure the laboratory equipment is maintained as per Good Laboratory Practices and cGMP

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company based in Hyderabad. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy manufactures and markets a wide range of pharmaceuticals in India and overseas.