Teva Analytical Researcher 

India, Goa 

375611822

• To perform the method transfer and method validation of microbiology samples for drug substances and finished products.
• Sound knowledge of Microbiology andMicrobiological testing of various products like in-process, finished products, Drug substances, excipient and stability samples etc.

• Shall have FDA approval in Microbiology
• To ensure the Initiation of the microbial method validation for the drug substances , excipient and finished products.
• To ensure submission of the microbial method validation summary report to Regulatory department.
• Preparation and updation of STP and analytical related SOPs.
• Regulated market experience (US/EU/Canada etc)
• Ensure the microbial methods for all the products are in place and testing is performed as per validated method.
• To ensure microbial culture media/ bioballs and other accessories availability in timely manner to have smooth operations in the lab.
• Review of the study protocols and Summary reports.
• To ensure timely testing and release of Water, Compressed Air, Stability Samples as per schedule and Raw material, Finished product as per production requirement.
• Reporting, investigation and close out of safety incidents encountered in the laboratory during Gemba rounds
• To ensure timely completion of all microbiology investigation investigation and close out as per due date.
• Active participation in regulatory Inspections, customer Inspection and Inspection observation compliance.
• To monitor activities in the laboratory as per Data Integrity requirements.
• To ensure timely revision of Standard Test Procedure and Standard Operating Procedures on need basis due to facility change or in line with Teva CORP Standards.
• To ensure upkeep and monitor all microbiology samples.
• Any other activity assigned by the line manager

• B.Sc. Microbiology with 5 to 11 Years of experience
• MSc. Microbiology with 4 to 9 Years of experience

Group Leader Quality Control