Pharmaceutical Compliance Specialist

3 days ago


Malmo, Skåne, Sweden Sever Pharma Solutions Full time
Job Description

We are seeking a Quality Assurance Manager to join our QA department. As a member of our team, you will play a critical role in ensuring the quality of our pharmaceuticals and combination products.

Main Responsibilities

  1. Manage environmental monitoring results and ensure compliance with regulatory requirements.
  2. Coordinate with external labs for microbiological analysis and communicate results to relevant stakeholders.
  3. Participate in Aseptic Process Simulation and Gas Cycle Development to improve manufacturing processes.
  4. Develop and implement effective deviation, OOS, change control, and complaint handling procedures.
  5. Collaborate with cross-functional teams to ensure seamless operations and high-quality products.

Requirements

  • Demonstrated expertise in quality assurance and regulatory compliance.
  • Strong analytical and problem-solving skills, with attention to detail and ability to work under pressure.
  • Excellent communication and interpersonal skills, with the ability to build strong relationships with colleagues and external partners.
  • A degree in Pharmacy, Natural Sciences, or Engineering, or equivalent experience in the pharmaceutical industry.


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