Senior Manufacturing Operations Manager
1 week ago
Global Life Science Hub is pleased to announce an opportunity for a Senior Manufacturing Operations Manager to join a prestigious pharmaceutical manufacturing organization.
About the Company:
This leading company is recognized for its dedication to innovation and excellence in the development of pharmaceutical dosage forms.
Key Responsibilities:
- Oversee the development of pharmaceutical dosage forms.
- Conduct thorough analysis of dosages in the manufacturing process.
- Ensure the monitoring and implementation of commercial, validation, and ANDA batches.
- Lead qualification processes including IQ, OQ, and PQ.
- Review and prepare ANDA documentation.
About Us:
The Global Life Science Hub specializes in connecting top-tier talent with opportunities in the life sciences and pharmaceutical sectors across Europe and the US.
Qualifications:
- Bachelor's degree (or foreign equivalent) in Pharmaceutical Science, Pharmacy, Chemistry, or a related discipline.
- At least 5 years of progressive experience in:
- ANDA (Abbreviated New Drug Application)
- IQ (Installation Qualification)
- OQ (Operational Qualification)
- PQ (Performance Qualification) validation
- SOP (Standard Operating Procedure) development
- Scale-up and technology transfer
- cGMP (current Good Manufacturing Practices)
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