Analytical Researcher
Goa, India, 403722
Who we are
The opportunity
- To perform the method transfer and method validation of microbiology samples for drug substances and finished products.
- Sound knowledge of Microbiology and Microbiological testing of various products like in-process, finished products, Drug substances, excipient and stability samples etc.
How you’ll spend your day
- 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
Your experience and qualifications
- B.Sc. Microbiology with 5 to 11 Years of experience
- MSc. Microbiology with 4 to 9 Years of experience
Reports To
Group Leader Quality Control
Teva’s Equal Employment Opportunity Commitment