Collins McNicholas

My client, Pharmaceutical Manufacturer locate din West County Galway is looking for Quality Control Technical Transfer.

The successful candidate will be responsible for:

Lead new method transfers to the QC lab and drive the timely 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.

  • Source and procure all equipment, materials and consumables associated with product transfer methods in a timely manner to ensure analytical work can be executed in line with project plans and day 1 launches.
  • Operate as the subject matter expert (SME) in the area of chromatography, and other areas related to analytical techniques, GMP execution, and become the point of contact for technical and troubleshooting assistance to the QC team.
  • Liaise 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-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in an effective and timely manner.
  • Take a senior analytical role within new projects, the analytical lead position, and drive the project towards timely and successful completion.
  • Compilation of technical reports to support analytical transfers, laboratory investigations, qualifications, trend evaluations.
  • Establish chromatography and wet chemistry training plans for QC analysts to ensure robust and compliant execution of analytical methods and to familiarize Quality reviewers with critical test method attributes.
  • Management of QC SOPs, change controls, deviations and IRFs associated with New Product transfers activity in QC laboratory.
  • Work closely with the stability program coordinator to ensure new products are placed on stability and that all elements of New Product test methods and specifications are in place for start of program.

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For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or email edyta.fleming@collinsmcnicholas.ie.

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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