Pfizer inc.- Jakarta, Indonesia (Indonesia)
Job Description
Responsibilities 1. Lead, direct, and develop the Quality Operations teams
2. Develop and communicate appropriate objectives, priorities, and PGS performance metrics consistent with PGS objectives and Global Quality Operations objectives
3. Serve as the chairperson of the Site Quality Review Team (S-QRT)
4. Promote cGMP, Pfizer Quality Standards, Good Practices Bulletin and others Policies to PGS teams
5. Establish Strong Quality System as a PGS best in class site
6. Develop and manage financial and staffing budgets to support Quality Operations activities.
7. Motivate colleagues through effective performance management and development planning.
8. Ensure that appropriate systems are in place to meet or exceed the requirements of the company and the regulatory authorities for the quality of the products manufactured on site or by approved vendors.
9. Implement appropriate plant self-appraisal processes to ensure compliance with Pfizer and regulatory requirements.
10. Manage the overall assurance and disposition of products produced in PGS-Jakarta or by approved contract manufacturing.
11. Working with the EM QOL to make decisions on Site quality issues.
12. Approve the quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.
13. Implement continuous improvement of manufacturing and quality control activities.
14. Lead Product Transfer of Pfizer products
15. Lead Packaging developments for products manufactured at PGS Jakarta
Desired Skills & Experience
- In-depth working knowledge of cGMP, Indonesia-GMP, others GMP and PQS- Knowledge and experience of both pharmaceutical manufacturing and quality operations
- Ability to lead and motivate a site quality team
- Excellent organizational, interpersonal and communication skills to work smoothly with people inside and outside of the PGS plant
- Ability to keep proper balances between quality and cost
- Strong influencing and negotiation skills with other departments and local health authority
- Ability to take the initiative at any time to implement continuous improvement, QRM, and Lean activities with a strong passion, aiming at the ideal plant
- Demonstrated ability to work in a matrix environment
- Good communication in English
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