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QC Manager

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Quality & Compliance
  • Date posted: 08/03/2018
  • Job reference: J382913A

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Quality Control Manager

SK biotek Ireland is seeking to hire a Quality Control Manager on a permanent basis.

Reporting to the Quality Director, the successful candidate will be responsible for the operation of the QC laboratory, ensuring that all laboratory operations are performed in line with regulatory requirements as well as providing input into the overall Quality strategy.


  • Manage the QC team to ensure that all tests are performed in a timely manner and QC records are completed to cGMP standards for the approval of raw materials, intermediates, active ingredients, in-process testing, cleaning analysis and stability analysis.
  • Monitor activities of the quality control group daily and provide leadership and technical expertise to ensure that targets are attained to meet customer delivery requirements. Ensuring the highest compliance standards are met.
  • Manage QC inspection readiness for all inspections and represent the QC in customer audits and Regulatory authority inspections.
  • Ensure laboratory investigations are initiated and investigated robustly and in line with regulatory expectations.
  • Seek opportunities to continually drive performance.
  • Manage the QC budget, oversee the purchasing process for the laboratory. Control operational expenses for laboratory and provide input into capital plan expenditures.
  • Provide Information/Metrics for Quality Council Meetings and Corporate Updates.
  • Provide Quality Data to Support APRs, Process Validation, Process Verification, Regulatory Filings, Specification Changes, Test Method Changes.

Education & Experience

  • The successful candidate will possess strong technical skills in laboratory analysis, Quality and people Management.
  • BSc in Chemistry or related discipline and at least 5 years' experience in the Pharmaceutical industry preferably in an API environment.
  • Analytical and Chemistry experience in a GMP- regulatory environment essential.
  • Excellent communication and organisational skills couple with previous supervisory experience and proven ability to drive performance of large team using lean methodologies are a pre-requisite.

For more information on this vacancy, please contact