AddressQuality Analyst III
Date: Mar 4, 2024
Location: Mumbai, India, 400059
Company: Teva Pharmaceuticals
Job Id: 54422
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 manage the EMSO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements.
This activity has the following aspects –
- Review change controls related API and FP specifications and analytical method of analysis, stability protocols etc., that are received from the CMOs.
- QC SME for change controls that need analytical evaluation.
- Review the method validation/verifications and method transfer reports associated with the change.
- Responsible to review QC investigations, OOS & OOT related to commercial and stability batches till approval
- Check for the adequacy of the investigations and coordinate with the CMO, internal stake holders to get the complete / compliant investigation
- On site investigations at CMOs as and when required to support business.
- Ensure proper investigation tools have been used to identify the root cause / probable causes.
- Review of the Pharmacopoeial and CEP assessments provided by the CMO and ensuring that the assessments are done within the timeline.
How you’ll spend your day
Change Controls:
- Initiate change controls related to EMSO but not limited to the batch manufacturing and packing records, specifications and analytical method of analysis, stability protocols etc., that are received from the CMOs.
Deviations and CAPA Management:
- Responsible to monitor investigations till approval.
APR (Annual Product Review)
- Review of APRs received from CMOs and APR summary preparation/approval.
- Ensure on-time implementation and closure of CAPAs resulting from CMOs APR review.
Pharmacopoeial and CEP Assessments:
- Review of the Pharmacopoeial and CEP assessments provided by the CMO and ensuring that the assessments are done within the timeline.
KPI Data management:
- KPI metrics management associated with CMOs for EMSO Quality.
- Compilation of monthly reports and any other scheduled EMSO Quality reports as required
Your experience and qualifications
- B. Pharm, / M. Pharm / M.Sc., B.Sc. (Science)
- Minimum 8 years of experience in pharmaceutical industry
- Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites.
- Knowledge of cGMP, Quality management Systems
- Knowledge on Compliance Standards and Regulation as applicable to the market.
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.
