Regulatory Compliance Specialist

1 week ago


Malmo, Skåne, Sweden Magle Chemoswed Full time

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:

  1. 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.
  2. Analytical Method Development: Oversee the development, validation, and maintenance of analytical methods, ensuring compliance with regulatory standards such as ICH Q3C, Q3D, and USP.
  3. Process Improvement: Drive process optimization initiatives to improve efficiency, reliability, and scalability in testing.
  4. Cross-Functional Collaboration: Coordinate efforts with R&D and manufacturing teams to support product development milestones.
  5. Regulatory Compliance: Ensure compliance with GMP standards and lead efforts during audits and regulatory inspections.

Qualifications:

  1. Degree in a Relevant Field: Degree in chemistry, pharmacy, or a related discipline.
  2. GMP Experience: Extensive experience in a GMP-regulated pharmaceutical environment, with a strong focus on analytical development.
  3. Leadership Experience: Proven leadership experience, with the ability to motivate and manage diverse teams.
  4. Expertise in Analytical Techniques: Expertise in analytical techniques, including advanced instrumentation like HPLC, UPLC, and FTIR.


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