Cipla Limited has announced an opening for the position of “Team Member – QA”.
Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, and depression; other medical conditions.
Cipla, as an organization has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple antiretroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility, and affordability to the center of the HIV movement. A responsible corporate citizen, Cipla’s humanitarian approach to healthcare in pursuit of its purpose of Caring for Life and deep-rooted community links wherever it is present, make it a partner of choice for global health bodies and stakeholders.
Job Title: Team Member – QA
Department: Corporate Quality Assurance
Qualification: B. Pharma. (minimum)/ M. Sc
Experience: 5-10 years
Work Location: Vikhroli, Mumbai, India
Deputy Manager – Third-Party Quality – Operations, Vikhroli, Mumbai
Review for Non – Sterile/sterile Contract manufacturing units, Review/ Evaluation/Approval of QMS of assigned CMO, Approval of P to P Product, and first batch release in compliance to regulatory and Cipla norms.
Unit Review:-Manage and review of cGMP conditions at assigned contract manufacturing units for regular manufacturing of Cipla Products by regular review of cGMP applications in products, process, and QMS documentation (executed batch records qualification, Change control(s), Deviation(s), APQR, Complaint Investigation (s), audit(s) and operational CAPAs, stability, risk assessments, recall, etc.) of contract Manufacturing Units thereby assuring the units stay in accordance with cGMP and Cipla requirements.
Quality Management of Assigned contract manufacturing unit-Evaluation/Approval of failure investigation, market complaints, and OOS / OOT investigation in coordination with manufacturing unit, technical, and other stakeholders in order to arrive at root cause and effective implementation of corrective and preventive action to avoid recurrence.
Cross functional activities/guidance/ supporting and timely resolution – Ensure timely Coordination and Significant interaction with cross functional teams (FPS/ Supply Chain / Regulatory Affairs / IPD / Cipla representatives / Cipla own unit & Contract manufacturer / Business / Marketing / Depot etc.) and external stake holders (Contract manufacturers / Regulatory agencies / Public Testing Labs, etc.) for resolution of any issues arises.
P to P Product Approval and Batch Release: -Manage and review of documents as per product approval checklist for principle to principle products approval in order to ensure errorless document within standard lead time to achieve production plan by issuing product approval form. Ø First / regular batch releases on priority by ensuring that correct inputs are provided to batch release team for decision on release of batches of the assigned and / or P to P Contract Manufacturing Units.
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