QC Analytical Specialist

PE Global is currently recruiting for a Senior QC Analytical Analyst for a leading multi-national Pharma client based in Dublin.

This is a 6 month maternity cover contract.

Role:

• Responsibility for defining, scheduling, coordinating, and driving to completion of all QC required sections for Annual Product Quality Review (APQR) reports.
• Responsibility for defining, scheduling, coordinating, and driving to completion all Annual Trend Reports.
• Support harmonisation of trending across BMS network sites.
• Responsibility for oversight and management of the Method Performance Monitoring Program, incorporating Reference Standard monitoring and invalid rate tracking.
  Management of trend related investigations, in association with the QC Analytical Trending Lead.
• Point of contact for internal and external manufacture sites, attend meetings where necessary.
• Co-ordination of trend assessments with the relevant SME’s and ensure delivery to meet due dates.
• Review trend limits from the manufacturing site and ensure timely implementation at CRU QC e.g LIMS.
• Addition of new products to the trending programme post successful transfer to the CRU QC teams.

Requirements:

• Minimum of a BSc in Biochemistry or related discipline
• Minimum of 3 years hands on experience in a GMP Laboratory Setting and QC Trending experience is preferable, preferably Biologics
• A strong fundamental understanding of protein biochemistry is desirable. Technical expertise should include the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, Bioassay) and compendial techniques (KF, HIAC)
• Previous experience with analytic laboratory data systems (Electronic Notebook, Velquest) would be advantageous.
• The successful candidate must demonstrate a problem-solving ability, as well as the ability to prioritise objectives from multiple projects.
• The successful candidate must demonstrate excellent time management and organisational skills. Excellent communication and the ability to contribute to and lead in a team based collaborative environment is essential.
  Interested candidates should submit an updated CV.

Please click the link below to apply, call Niamh on +353 83 2033710 or alternatively send an up to date CV to niamh.mcdonald@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***