Regulatory Affairs Manager
6 days ago
We believe that true capabilities result from deep knowledge, experience, and having the right personnel in place. We foster a culture where amazing people can do their best work and grow their careers.
Key Responsibilities
- Trend environmental monitoring results and manage samples/results sent to external labs for microbiological analysis.
- Act as a contact person for external labs handling microbiological tests and participate in Aseptic Process Simulation and Gas Cycle Development.
- Handle deviations, out-of-specification (OOS) results, change controls, and complaints effectively.
- Write, review, and approve quality documentation, including batch documentation and release of bulk and intermediates.
- Provide support to other departments within the company.
What We Offer
- A competitive salary and benefits package.
- Ongoing training and development opportunities to enhance your skills and career growth.
- A dynamic and collaborative work environment with a passionate team.
- The opportunity to work on challenging projects and contribute to the success of our company.
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