QA Manager (Regulatory/ West, Pharma MNC)
- Manage New Product Introduction (NPI) projects , product-related registration strategies, Pre-Approval Inspection readiness
- Ensuring regulatory documentations meets relevant regulatory requirements
- Lead and coach team members to deliver site commitments on time.
- Provide leadership to ensure all site quality and regulatory system and operations remain in full compliance with regulatory filing and submissions.
- Provide regulatory input to the site compendial monitoring review program in line with global regulatory requirements
- Work with GCMC team and providing inputs to the development and implementation of regulatory product strategies and activities for manufactured products
- Coordinates with GCMC and local regulatory authorities on the preparation of regulatory filings, identification of issues and factors that may implicate regulatory strategy or activities.
- Regularly follow up with GCMC/PCO/WSR/RA on progress of registration submission and approval activities.
- Instigate a culture of lean operations by reviewing existing work practices and reducing non-value added activities in a systematic manner
- Degree in Science / Engineering or related science.
- Minimum 8 years of directly related experience in pharmaceutical manufacturing and quality operations, or equivalent combination of work experience and education
All qualified applicants, please send in your resume to:
[Click Here to Email Your Resume]
Attention to: Tricia Goh
Or call 6736 3280 for a short discussion
Please include your full working experience, education background, notice period, expected salary.
We regret to inform that only suitable candidates will be shortlisted for an interview.
Tricia Celestine Goh (R1981653)
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