Quality Assurance Manager
2 weeks ago
About Us:
Magle Chemoswed is a trusted CDMO dedicated to enabling life-changing therapies for patients worldwide. We specialize in delivering comprehensive solutions across the pharmaceutical lifecycle, from early-stage drug development to commercial manufacturing.
Our Mission:
We aim to bring innovative biopharmaceuticals to market, leveraging cutting-edge technologies and GMP facilities in Malmö, Sweden. Our team of experts collaborates with partners to develop, manufacture, and optimize high-quality pharmaceuticals that impact patients' lives globally.
The Role:
We are seeking a dynamic and motivated QC Manager to lead and inspire our Quality Control team. As a key member of our organization, you will oversee analytical method development, validation, and impurity profiling to ensure regulatory compliance.
Your Responsibilities:
- Team Leadership: Manage and develop a team of QC scientists, fostering a culture that reflects our company values with a focus on quality and continuous improvement.
- Analytical Method Development: Oversee the development, validation, and maintenance of analytical methods, ensuring compliance with regulatory standards such as ICH Q3C, Q3D, and USP.
- Process Optimization: Drive process optimization initiatives to improve efficiency, reliability, and scalability in testing.
- Cross-Functional Collaboration: Coordinate efforts with R&D and manufacturing teams to support product development milestones.
- Regulatory Compliance: Ensure compliance with GMP standards and lead efforts during audits and regulatory inspections.
Your Qualifications:
- Degree in a Relevant Field: Degree in chemistry, pharmacy, or a related discipline.
- GMP Experience: Extensive experience in a GMP-regulated pharmaceutical environment, with a strong focus on analytical development.
- Leadership Experience: Proven leadership experience, with the ability to motivate and manage diverse teams.
- Expertise in Analytical Techniques: Expertise in analytical techniques, including advanced instrumentation like HPLC, UPLC, and FTIR.
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