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- Responsible for preparation of Annual quality review /periodic quality review.
- Responsible for handling change control system.
- Editing & Reviewing of SOP's in Smarteam system
- Responsible for the effective implementation of CAPA and to review of CAPA effectiveness.
- Responsible for performing ERP/LIMS/SMARTEAM activities which is defined in their privilege.
- Responsible for reviewing the executed and master batch card.
- Control, distribution & archiving of master documents.
- Coordination and review of validation (Process and cleaning) and qualification documentation (Qualification includes all equipment's, facilities, process water,utilities, HVAC and others.
- Responsible for coordination in internal as well as in external audits.
- Providing cGMP /SOP/General trainings.
- Coordination for technology Transfer/Site transfer documentation for new products
- Participation in Internal audit programs to ensure the compliance of quality system.
- Responsible for reviewing the investigation initiated due to deviation, OOS, LIR complaints, audits or any incidents. He I She is a part of investigation team.
- Responsible for supervising of dispatch activity
- Responsible for handling the reprocess, rework, return material.
- Coordination for vendor approval procedure
- Responsible for supporting to customer experience, Regulatory affairs or other external department requirement.
- Responsible for preparation and update of Site Master File and Validation master plan
- Responsible for performing quarterly/Periodic trend analysis on Human error, Environment monitoring, Water quality, complaints and others.
- Responsible for performing general activity like Mock recall, Shipping validation, Risk assessment and others.
Quality Specialist III - Gwalior, India - Teva Pharmaceuticals
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.How you'll spend your day
JD Contd...
Your experience and qualifications
Education- MSC
Education- 3-5yrs