- Assisting with the oversight of the supply chain, manufacture and packaging of pharmaceutical products in various Contact Manufacturing Organizations.
- Reviewing of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending batch release.
- Reviewing and approving standard operating procedures, master batch records and product specifications.
- Providing Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
- Assisting with periodic audits, reviews of contract manufacturers and/or regulatory inspections.
- 5+ years' experience in a cGMP regulated drug substance, drug product manufacturing and/or packaging environment,
- Proficiency in Quality Assurance and Compliance.
- 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.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
- Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences)
For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 / marcel at sigmar.ie
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