One of the global biotechnology companies based in Cork, is seeking a Qualified Person to join their international Quality department in a 12 months contract role.
Qualified Person job responsibilities :
Ensure that, prior to the certification of any given batch of formulated bulk drug substance, drug product and finished goods, each batch has been manufactured and tested in accordance with the requirements of its Marketing Authorization or Product Specification file and the principles of current Good Manufacturing Practice (cGMP) prior to final release of the batch.
Be responsible for the Quality oversight of contract manufacturers, testing and for leading, monitoring and supporting the quality performance of quality systems according to GMP standards.
Take part in Material Review Boards, CMO Quality Reviews, Supply planning and Product Governance Meetings.
Partner with departments across the company and with CMO’s providing Quality Oversight of CMO’s.
Job skills and experience :
M.Sc. with at least 8 years of experience, or B.S. with at least 10 years’ experience in an EU licensed facility in a relevant functional area.
Maintain knowledge up-to-date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.
Ability to speak, present data, and defend approaches in front of audiences and inspectors.
Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
Contract - Full time (40hrs week)
Package : Negotiable
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 /
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