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 a multinational pharmaceutical company based in Hyderabad, India. The company was founded in 1984 by Kallam Anji Reddy. Dr. Reddy's manufactures and markets a wide range of pharmaceuticals in India and overseas.
Dr. Reddy's is committed to providing access to affordable and innovative medicines. The company has three businesses:
Pharmaceutical Services & Active Ingredients
Global Generics
Proprietary Products
Dr. Reddy's products include:
Carboprost Tromethamine Injection, USP
Daptomycin for Injection
Ertapenem for Injection
Fondaparinux Sodium Injection