Job Description

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

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

• 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

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

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Job Tags

Similar Jobs