الوصف الوظيفي
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 To manage the EMSO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements.
This activity has the following aspects –
• Life cycle management of Change control system
• Responsible to follow the Quality Management System of EMSO organization, which is relevant to the job function
• Review of APRs
• Preparation of Standard Operating Procedure
• Training Management
• Document Management
• Batch record review.
How you’ll spend your day 1. Change Controls:
Life cycle management of change control in Global Trackwise system as co-ordinator.
Initiate change controls related to the batch manufacturing and packing records, specifications and analytical method of analysis, stability protocols etc., that are received from the CMOs.
Evaluate the change controls for adequacy and perform line by line review of the documents.
Review validation/qualification and other associated supporting documents required with the change.
Follow up with internal stake holders and monitor the movement of change controls throughout its lifecycle.
Hands on knowledge on variation documents and requirements
2. APR (Annual Product Review):
Co-ordination for APR review plan and execution with APR team.
Review of APRs received from CMOs.
Ensure on-time implementation and closure of CAPAs resulting from CMOs APR review.
3. Training system Management: Ensure training completion in LMS and management of training records.
4. KPI Data management:
Collate, manage and provide the data required for EMSO Quality to represent in the business review meetings, Quality Councils and any other applicable review meetings.
5. Document Lifecycle Management:
Storage and retention of the approved GMP documentation as per the defined archival period.
6. Global/Regional Projects: Drive the projects identified by the Quality department and support the projects driven by the EMSO Operations team.
7. Batch Records review: Review of batch documents to support batch release process.
Your experience and qualifications
M. Pharm / M.Sc. (Science), B. Pharm
Pharmaceutical Sciences / Life Sciences
Minimum 5 - 8 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.
Reports To Associate Director, Quality Assurance
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