Manager Quality Assurance

Found in: beBee S IN - 4 weeks ago

Bangalore, India Teva Pharmaceuticals Full time
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

This role acts as a member of Teva External Manufacturing and Supply Operations (EMSO) & ensures compliance of the EMSO Quality Systems with Regulatory requirements and Teva Quality Management Standards. The role is responsible to ensure timely decisions to Teva EMSO Supplier Relationship team (SRT) and CMOs on all issues related with NTM/GNTMs, & responsible for monitoring Quality Management System at EMSO APAC.

How you’ll spend your day
  • To manage the EMSO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirement such as Responsible to follow the Quality Management System of EMSO organization, which is relevant to job function, Management of NTM/ GNTM, Training Management, CAPA management., Global Projects Monitoring, Document Management, Quality Management System.
  • Ensure storage and retention of the GMP documentation as per the defined retention period.
  • Ensure timely completion of impact assessment and risk assessment related to NTM/GNTM and participate in QAM / CVI meetings.
  • Provide timely decisions to SRT and CMOs for issues related to NTM/ GNTMs.
  • KPI Metrics management for EMSO Quality and ensure no overdue Change controls, Deviations and CAPAs.
  • Monitoring Change Control Board for EMSO APAC
  • KPI metrics management associated with CMOs supplying products to EMSO through monthly dashboards.
  • Ensure completion of CMO risk assessments as per defined frequency.
  • Responsible for data analysis and compilation to report in Monthly Dashboards, Quality Councils, Quality Business Reviews and any other applicable review meetings.
  • Ensure timely completion of CAPAs and no overdue CAPAs.
  • Responsible for providing timely responses to the audit observations for the audits conducted at EMSO APAC.
  • Responsible for implementation of CAPAs related to any audit observations.
  • Responsible for preparing and monitoring self-inspection schedule and conducting self-inspection as per the schedule at EMSO Quality APAC.
  • To approve Complaint investigations, Deviations, Change controls and extensions related to these records
Your experience and qualifications
  • Minimum 10-15 years of experience in pharmaceutical industry
  • Knowledge of cGMP, Quality management Systems and the pharmaceutical manufacturing, supply chain environment
  • Knowledge on Compliance Standards and Regulation as applicable to the market.
  • Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites.
  • Knowledge and working experience with USFDA / EU and other competent authority approved sites.
  • M. Pharm / M.Sc.
Reports To

Sr Dir Commercial Quality_EMSO Quality APAC 

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