Regulatory Compliance Project Coordinator
6 hours ago
We are seeking an experienced MSAT Project Manager to join our team at Essential Pharma, a leader in specialty pharmaceuticals. In this role, you will play a crucial part in ensuring the smooth transfer of pharmaceutical products from manufacturing sites, while maintaining compliance with regulatory requirements.
Your responsibilities will include:
- Reviewing and approving relevant technical documentation, including product quality documents, certificates of analysis, stability data, BMRs, PQRs, and risk assessments
- Working closely with M&A to manage technical reviews and due diligence of target medicines for potential acquisition initiatives
- Driving the use of analytical data to make adaptations and improvements to manufacturing processes
What You Will Bring:
- Significant experience in site tech transfer, including wide exposure to pharmaceutical manufacturing, QC testing, and packaging
- Experience across biologics and small molecules, with adaptability essential to success
- A demonstrable track record of successful project management and execution in relation to tech transfer
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