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Senior QA Associate

Job description

QA Associate role where you can really contribute by providing support for external contract manufacturing operations.
Job responsibilities:
  • 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.
Job requirements:
  • 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)
This is an initial 12 months contract. (No shift work required)

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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