Job 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.

The opportunity

Maintaining a Quality assurance system in according with up-to-date requirement of the regulatory authorities. Maintaining a set of procedures that support the Quality assurance system. Responsible to release / reject the material / batch includes the review and approval of related manufacturing and analytical documents. Review, approval and maintaining of the documents / master documents related to monographs, Validation master plan, site master file, Laboratory information file, SOP\'s, equipment qualification, general system validation, batch cards, process validation, cleaning validation and other production related data.

How you\'ll spend your day

• Basic GMP, refreshing GMP/ data integrity training & SOP training to all company employees and contract workers.
• Handling of customer and regulatory inspections, Audit Compliance report and related CAPA and follow up, Plant QA round for monitoring GMP compliance.
• Handling of customer queries and complaints & Change control Management.
• Carrying out quality system audits / internal audit to verify compliance with principles of GMP.
• Coordinating in investigation and closing of deviation, LIR, OOT and OOS results and market complaints. Follow up and implementation CAPA with effectiveness verification.
• Review and verification of documents and update in computerized system.
• Coordination in vendor qualification and approval activities.
• Coordination for preparation of Approved manufacturer / vendor list.
• Performing vendor / service provider audits as and when required.
• Review and archival of technology transfer documents and Performing tech transfer / site transfer activities as per Teva policy.
• Stability sample initiation for validation batches, annual batch and others.
• As an Opex champion, identification of improvement projects in respective areas and supporting functional head to implement the project with targeted OTIF.
• Estimating the base line performance and implementation of OPEX in respective areas to achieve the targeted continuous improvement in cost, quality, compliance and EHS.
• Monitoring and review of energy consumption in respective areas and initiating the CAPA if it is out of trend/off the track.
• Responsible for assisting Site QA Head for implementation of QA activities in plant and approving all related documents as a proxy to Site QA Head.

Your experience and qualifications

• 12+ years\' experience in QA with 7+ years\' experience in QMS.
• Should be MSc Chemistry/B Pharma/M Pharma/Bio-Analytical
• Should have experience in Track Wise, LIMS, ERP

Reports To

Sr Mgr Quality Assurance

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.

Teva Pharmaceuticals