Senior Micro Quality Control Specialist

Job Title: Senior Micro Quality Control Specialist
Contract Type: Permanent
Location: Dublin
REF: 123582
Contact Name: Gavin Kennedy
Contact Email:
Job Published: almost 3 years ago

Job Description

Senior Micro Quality Control Specialist
  • QC oversight of our client’s contract test laboratories utilized for release testing and on-going stability testing
  • Interpretation of data trends for both release and stability, life cycle of methods in alignment with the QC method development team and other technical support as required.
  • Drive investigations with strong understanding of compliance and cGMP's, strong scientific judgment in decision making.
  • The scope includes drug substance and drug product
  • Works with our clients external CMO/CTL partners and internal Quality teams within this department. In addition this function works closely with External Supply, Supply Planning, Technical support and other stakeholders involved in external supply.

  • Building/sustaining collaborative relationships within Quality, and stakeholders across the organisation
  • Regularly interacting with internal and external stakeholder groups to understand needs and collaboratively resolve issues in order to meet patient and business needs
  • Timely testing and reporting of accurate data
  • Supporting method transfer projects and lab audits/inspections
  • Supporting the establishment and revision of product specifications
  • Expeditiously and objectively investigating laboratory exceptions and supporting manufacturing investigations. Escalates where further input is required
  • Timely trending of data and operational key performance indicators
  • Identifying and/or remediating technical, compliance, and efficiency gaps
  • Anticipating, monitoring and addressing evolving and new regulatory requirements
  • Authoring/reviewing regulatory submissions
  • Establishing/improving technology solutions to support people and processes
  • Providing accurate and timely updates of group activities to Quality and Technical Operations management with a focus on compliance, cycle times, cost management, and productivity

  • Ph.D. in Chemistry, Biology or other related fields, or BSc/MSc with >6 years of relevant experience.
  • Thorough understanding of quality systems and cGMPs.
  • Experience conducting lab audits and/or involvement in preparation for Health Authority inspections.
  • Interpersonal skills and communication skills to interact with CMO/CTL partners and other functions.
  • Must be able to prioritise in a busy environment.
  • Must be able to travel -approx 20% (domestic and international)
  • Must be fluent in English

For further information on this QC Specialist position please contact Gavin Kennedy at The RFT Group on 01 2302400 / Check out all our open jobs on our Recruitment Website:
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