External Quality Associate

  • Contract
  • Cork

Website Ref: TPM04219

Summary:
A QA Analyst is required for a biopharmaceutical company in Cork. The incumbent will be responsible for supporting quality systems, assisting with the batch release process of drug product and pack label finished goods orders produced by external Contract Manufacturing Organizations (CMO’s).

Responsibilities:

  • Assist with quality oversight of the supply chain, manufacture and packaging of products in various CMO’s.
  • Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending final batch release.
  • Review and approve standard operating procedures, master batch records and product specifications.
  • Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
  • Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
  • Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
  • Assist with regulatory requests and inspections.
  • Artwork review and approval.
  • Assist with new market launches.
  • Support the following activities, as appropriate:
  • Quality Deviations.
  • Change Controls.
  • Updates to relevant quality technical agreements.
  • Validation activities.
  • Audits internal & external.
  • Annual Product Reviews.
  • External customer complaints.
  • Recalls and/or notification of events to regulatory agencies.

Qualifications & Experience:

  • Bachelor of Sciences (B.Sc.) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
  • A minimum of 5 years’ experience in a cGMP regulated FBDS, drug product manufacturing and/or packaging environment is a pre-requisite for application, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
  • Ability to comprehend technical information related to equipment, manufacturing 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.
  • Excellent interpersonal skills with the ability to work as part of a dynamic team and efficiently engage both interdepartmentally and with external CMO’s.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.