Quality Control Analyst II
Goa, India, 403722
We Are Teva
We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.
How you’ll spend your day
- Receipt, registration and upkeep of samples in the laboratory.
- Review of analytical data.
- Preparation and review of analytical protocols/reports
- Online monitoring of trends and analytical results of all applicable products
- Data compilation, Calculation, Documentation and general upkeep of Action/Alert Limits
- Review and submission of Annual Product Review (APR) documents to QA Department
- Upkeep and Maintenance of incubators, walk in chambers, refrigerators, stability area and Stability Chambers.
- Intimation of field alert report to QA.
- Identification, tracking and Co-ordination of all stability batches packed at Goa site and at other approved packing site.
- Sending samples to external laboratories for testing.
- Provide technical guidance to team members.
- Adherence to committed timelines to achieve “Cycle Time (CT)” target.
- Define the analytical strategy to develop/verify/validate or transfer of analytical methods for new and ongoing projects.
- Ensure maintenance, upkeep and inventory of spares, accessories, columns, glassware, chemicals, standards, narcotic substances, placebos and impurities.
- Responsible for regulatory compliance.
- Handling of instrument/equipment breakdowns
- Co-ordination with service providers for instrument related services
- Review and Monitoring of preventive maintenance/ performance verification / calibration of instruments / equipment’s.
- Responsible for creation, verification and review of non-computerized and computerized systems in Laboratory
- Review of analytical data generated by various analytical methods/techniques in view of data integrity and Audit trails.
- Approval of Analytical reports subject to FDA approval
- Timely evaluation of Pharmacopeia changes and implementation of the same.Ensure timely qualification of in-house standards
- Responsible for reporting and investigation of Analytical Errors, Out of Action/Alert Limits, Deviations and LIR (If any).
- Ensure CAPA closeout and effectiveness check.
- Responsible for trackwise, Ample Logic and Glorya EDMS related activities
- Responsible for SAP related Activities.
- To ensure compliance to the policy and procedures requirements on Data Integrity.
- Review of Microbiological data
- Ensure timely completion of assigned trainings.
- To maintain Good Laboratory Practices
- To maintain the laboratory cleanliness and continuous monitoring.
- Ensure maintenance of logbooks and all relevant registers in the laboratory.
- Routine troubleshooting during analysis.
- To involve in OpEx initiatives.
- To impart awareness and refresher training
- To maintain cross functional and cross departmental communications
Your experience and qualifications
- 10+ Years of experience
- M.Sc/M.Pharm
How We’ll Take Care of You
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.
When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
Teva’s Equal Employment Opportunity Commitment