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QC (Chemistry) Team Lead, Galway



Galway, Ireland 

Job Category:

Biotech/Pharma, Science

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Job Description:

The Opportunity

Team Horizon is seeking a QC Team Lead who will be responsible for the co-ordination of analytical, documentation and compliance activities assigned to the QC Laboratory. The successful candidate will lead and develop team of QC Analysts and will coach and developed team to their full potential. This role is based in the West of Ireland.

The Role

  • Development and leadership of a core team of QC analysts, which includes mentoring, training, appraising performance and supporting individual Development Plans
  • Schedule, Co-ordinate & Supervise all analytical activities within the QC Laboratory ensuring all activities are carried out in a timely manner to meet company objectives and relevant key performance indicators
  • Co-ordinate efficient and robust QC sampling routines covering API, utilities, final product and method transfers with timely production of relevant QC Documentation including Protocols, Reports, Analytical data sheets, SOPs, change controls, deviations and IRF’s
  • Review and approve non-chromatographic and chromatographic data. Review and approve filled product, raw material and stability analytical data sheets in a timely manner to meet company objectives. Support QA personnel in close out of QC batch release and stability program issues
  • Co-ordinate and supervise laboratory investigations to ensure they are captured, documented and actioned with close out in a timely manner. Ensure OOS results are escalated and where relevant FARs are required they are initiated within the required timeline. Compilation of technical reports to support laboratory investigations, qualifications, trend evaluations Lead the chromatography and wet chemistry training of QC analysts
  • Lead the chromatography and wet chemistry training of QC analysts
  • Management of QC SOPs, change controls, deviations, CAPAs and lab investigations. Ensure cGMP compliance is maintained in the QC laboratory at all times
  • Co-ordinate instrument calibrations & maintenance and qualification to specified schedules
  • Support continuous improvement projects such as 6S and lean processes for the laboratory. Participation in internal audit and laboratory walkthrough programs and represent the QC laboratory in third party inspections as required Provide input to regulatory files in support of new product submissions and approvals.
  • Act as Designee/Deputy for QC Manager

The Person

  • Minimum of a Bachelor's degree (or equivalent) in a Science related discipline (Chemistry, Biochemistry or Analytical science) and 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
  • Strong technical writing skills
  • Working knowledge of Empower, LIMS and other lab software systems
  • Computer skills (MS Office, Trackwise, Minitab)
  • Strong analytical skills with excellent attention to detail
  • Communication skills both verbal & written with good time management skills
  • Ability to lead of a team to meet business demands
  • Position directly supervises up to 10 employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
  • Proficiency in speaking, comprehending, reading, and writing English is required

Employment Type:

Full time
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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