Job title: Quality Specialist III
Company: Teva Pharmaceuticals
Job description: Who are we?
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
Job Description
- Review and approval of executed batch cards and other production related data.
- Control, distribution & Archival of all documents.
- Responsible for coordination and supervising dispatch and related activities.
- Responsible for initiation, review of change controls system related to process, monograph, facility, SOP’s, vendor etc.
- Coordinating for investigating, review and closing of deviation, OOS, OOT, CAPA and related task. Follow up and implementation CAPA with effectiveness verification.
- Coordination and review of Qualification/Validation documents and engineering files and related task.
- Carrying out quality system audits / internal audit to verify compliance with principles of quality system GMP / GLP.
- Coordination, review and archival of technology transfer documents. Review and update of time limitation and process parameters.
- Coordination in stability sample initiation for validation batches, annual batch and others.
- Review and verification of documents and updation in computerized system.
- Filling of Customer Questionnaires and other customer related Queries.
- Responsible for preparation and review of annual product review.
- To perform the risk assessment.
- Batch card auditing & retrieval.
- To ensure the cGMP compliance and compliance of audit CAPA.
- Plant QA round for monitoring cGMP compliance.
- Carrying out of Basic GMP, Refreshing GMP, data integrity and SOP training to all company employees and contract workers.
- Performing and coordinating Vendor qualification / approval activities.
- Preparation of Approved manufacturer list.
- Any other job assigned by Site QA head / Head of Quality Function TAPI India.
Qualifications
BSc/ MSc/Bpharm/ Mpharm
3+ years of experience
Function
Quality
Sub Function
Manufacturing Quality Assurance
Reports To
Assoc Dir Plant/Site Qlty Assur
Already Working @TEVA?
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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.
Expected salary:
Location: Gajraula, Uttar Pradesh
Job date: Sat, 11 Jun 2022 06:40:20 GMT
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