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Details

Sr Associate QC


Reference:JSC00029344 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst


We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


Duties

•Supporting drug product analytical method transfers to international government / contract labs as part of 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 Amgen reference standards, critical reagent and commercial materials.
•Working collaboratively with other functions within the 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
• Be very proficient in the use of Microsoft Word, Excel etc.
• Have strong technical writing skills.
• Be detail oriented, self-motivated with good troubleshooting and problem solving abilities.
• Be a self-starter and capable of working on own initiative.
• Strong team work skills.
• Proven track record of meeting deadlines.
• Experience with analytical techniques such as HPLC, Bioassay and Compendial testing would also be advantageous
•Advantageous if the candidate has lab experience, to take on some data review work, and to be a SME to cast an eye of paperwork
•Good strong technical writer, good communications skills, working cross functional, internally and externally


Education & Experience

•Candidates will need to knowledge how a GMP lab works, - all of the reports worked on will be part of analytical test methods. If the candidate has lab experience, we expect them to have investigation, report writing, writing SOPs. Will consider candidates with GLP experience, but GMP is preferred, main thing the candidate is a strong technical writing.
•Have at least 2 years relevant experience in a pharmaceutical/healthcare environment.
•Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology or Biotechnology
•Experience with analytical techniques such as HPLC, Bioassay and Compendial testing would also be advantageous
•Advantageous if the candidate has lab experience, to take on some data review work, and to be a SME to cast an eye of paperwork


If you would like further Information you can contact the recruiter directly:


Jack Caffrey | Tel: +353 (0) 1 507 9279