Manufacturing Oversight Specialist

3 days ago


Ottawa, Ontario, Canada MoonLake Immunotherapeutics Full time
About the Role

The Manufacturing Oversight Specialist will play a critical role in ensuring the quality and integrity of our manufacturing processes. This individual will work closely with cross-functional teams to identify and mitigate potential risks, implement corrective actions, and maintain compliance with regulatory requirements.

Responsibilities
  1. Maintain awareness of international GMP compliance requirements relevant to MoonLake's drug-product-device combination products.
  2. Collaborate effectively with the Senior Manager GMP Quality to ensure GXP compliance of contractors for drug product manufacture and testing.
  3. Develop and implement quality assurance procedures to ensure compliance with regulatory requirements.
  4. Provide training and support to colleagues on quality-related matters.
Qualifications
  • A scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry, or related).
  • Some experience of working in Quality functions in a pharmaceutical/biotech or device manufacturing environment, specifically in batch review/manufacturing oversight.
  • Strong analytical and problem-solving skills.
  • Ability to work proactively using own initiative within a matrix team structure.


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