This role will be responsible for coordinating, facilitating, and undertaking activities pertaining to transfer of analytical methods to international government / contract labs as part of our client's global sales expansion. The role also represents the QC unit by liaising with internal and external customers.
• Supporting drug product analytical method transfers to international government / contract labs as part of the client's global sales expansion.
• Management of various aspects of the analytical method transfer process (e.g. tracking of transfer milestones, preparation and approval of analytical method transfer plans and reports and ensuring adherence to transfer requirements).
• Completing subject matter expert data review of International lab method run results where required.
• Working collaboratively with other functions within the company's network and international labs (e.g. International Quality, Regulatory, Supply Chain and Logistics).
• Support the management team with the visual management board and tracking KPIs for the IAS group.
• Competent in the use of document management systems such as EDMQ/CDOCS.
• Third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology or Biotechnology.
• At least 2 years relevant experience in a pharmaceutical/healthcare environment.
• Strong technical writing skills.
• Experience with analytical techniques such as HPLC, Bioassay and Compendial testing would also be advantageous.
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