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QC Associate

  • Job reference: 930590
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/03/2020

Orion Group Life Sciences are looking for a QC Associate for our Multinational Pharmaceutical client based in the South of Dublin area on an initial 12-month contract with the potential to extend.

Job Purpose

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 the client's global sales expansion. The role also represents the QC unit by liaising with internal and external customers.

Main Responsibilities of the role

  • Supporting drug product analytical method transfers to international government / contract labs as part of the company'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
  • Providing analytical support for drug product registration/import testing in International labs, through management of the shipment of company reference standards, critical reagent and commercial materials
  • Working collaboratively with other functions within the company 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

Desired Experience and Background of the successful candidate

  • Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology or Biotechnology
  • Have at least 2 years' relevant experience in a pharmaceutical/healthcare environment
  • Be very proficient in the use of Microsoft Word, Excel etc.
  • Have strong technical writing skills
  • Candidates will need to knowledge how a GMP lab works, - all of the reports worked on will be part of analytical test methods
  • Experience with analytical techniques such as HPLC, Bioassay and Compendial testing would also be advantageous
  • Experience in investigation, report writing & writing SOPs
  • GMP is preferred
  • Be a self-starter and capable of working on own initiative and Strong team work skills
  • Proven track record of meeting deadlines.
  • Be detail oriented, self-motivated with good troubleshooting and problem solving abilities
  • Working cross functional, internally and externally

#pharmaceutical #pharma #multinational #product #bioassay #biotechnology #QC #qualitycontrol #technicalwriting #EDMQ #CDOCS #HPLC

For more information on this role, call Kate O' Sullivan on +353 (0) 212063412 or email for a completely confidential chat about this role and other opportunities using the reference number: 930590

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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