Regulatory Compliance Specialist
1 week ago
Company Overview:
Magle Chemoswed is a leading CDMO dedicated to delivering comprehensive solutions across the pharmaceutical lifecycle. From early-stage drug development to commercial manufacturing, we provide expert services to bring innovative biopharmaceuticals to market.
Our Team:
We have a talented team of experts who collaborate with partners to develop, manufacture, and optimize high-quality pharmaceuticals. Our team includes experienced professionals in analytical development, regulatory compliance, and process optimization.
Job Responsibilities:
- Team Management: 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 Improvement: 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.
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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