Urgent Executive

1 week ago

Pune Maharashtra, India LUPIN Full time

Timely testing with online documentation of various sample stages including in-process intermediate drug substance drug product stability samples of Biotherapeutics proteins for test parameters including but not limited to HPLC methods Host cell DNA contaminants quantification by RT PCR Host cell protein contaminants quantification by ELISA Electrophoresis ELISA based assays and general procedures including but not limited to extractable volume sub-visible particle testing pH conductivity Should work in shifts Preparation of reagents solutions required for routine testing and maintenance of their records Preparation and periodic updation of SOPs STPs and Specifications pertaining to testing of Biotherapeutics Perform In-house calibration verification of Analytical equipment as per the approved procedures and calibration verification frequency Online monitoring and maintenance of equipment records To ensure cGMP compliance and maintain the laboratory in audit ready condition To report any Deviations Out of Specifications results and Safety risks to the supervisor as and when observed Participation in transfer of analytical methods from R D to QC To attend all GMP On-job additional trainings as per the approved training matrix and update the training records Work Experience Experience 5 - 8 years in Quality Control Education Post Graduation in Biotechnology or Biochemistry Competencies

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