Quality Control Tech Transfer Analyst

This leading generic and speciality pharmaceutical company maintains one of the industry’s broadest and highest quality portfolios. With more than 1,400 high quality generic, branded and over-the-counter products, they cover virtually every dosage form and therapeutic category, from cardiovascular, osteoporosis and gastrointestinal diseases, to central nervous system, antihistamines, diabetes and antibacterial. With over 30,000 employees worldwide and a revenue of almost $12 billion in 2017, this company is passionate about providing quality health care to the world’s 7 billion people, one person at a time. The company’s most recent Irish expansion outlined an annual investment of up to €76 million ($100 million). Due to this continued growth of the company in Ireland, a role has arisen for a Quality Assurance Executive to be based in their state of the art facility in the West of Ireland.

The Role:

The Quality Control Tech Transfer Analyst will be responsible for:

  • Leading new method transfers to the QC lab and driving performance of complex analytical and chromatographic testing of raw materials, finished product, stability samples, for products being transferred from Product Development on site or from external sites
  • Sourcing and procuring all equipment, materials and consumables associated with product transfer methods to ensure analytical work is executed in line with project plans and day 1 launches
  • Operating as the subject matter expert (SME) in the area of chromatography and other areas related to analytical techniques
  • Becoming the point of contact for technical and troubleshooting assistance to the QC team
  • Liaising with cross-functional teams such as analytical development, manufacturing and regulatory affairs to ensure method transfer deliverables are understood and communicated within the QC team
  • Co-ordinating and supervising laboratory investigations to ensure they are captured, documented and actioned with close out in an effective and timely manner

The Person:

The ideal candidate will have:

  • Minimum of a Bachelor’s degree (or equivalent) in a Science related discipline (Chemistry, Biochemistry or Analytical Science)
  • 5-7 years’ of relevant industrial experience
  • Previous HPLC/GC/ peptide analysis experience in method validation / transfer (preferably with Empower software) is essential
  • Strong working knowledge of chemistry / biochemistry (chromatographic, wet chemistry and peptide analysis) techniques
  • Knowledge of cGMP, Empower and other lab software systems
  • Computer skills (MS Office, Trackwise, Minitab)
  • Validation experience

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.

Salary: On Application Location: Galway