Dr.Reddys job opening for QC Associate – Bioassay Apply Now
Job Description:
The candidate should have experience in basic cell culture techniques and in Bioassay testing.
Test samples for Commercial and Stability batches
Test the samples as assigned & release the data as per defined timelines – Commercial, Stability & Campaign batches
Ensure that no executional errors occured against set procedures
Ensure that required reagents, buffers are prepared according to the testing plan and equipments are available for analysis IN ORDER to ensure smooth completion of analysis within turn around time.
Document and repoort test results
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 investigation of failure tests and QMS
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
Ensure compliance to Good Laboratory Practices
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
Laboratory Equipment management
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
Department: Biologics
Open Positions: 1
Skills Required: Bioassay
experience with understanding of GMP operations
Location: Bachupally, Hyderabad, Telangana, India
Education/Qualification: M Sc
Years Of Exp: 04 to 08 Years
Designation: QC Associate – Bioassay