Compliance Officer

2 weeks ago

Nenagh, County Tipperary, Ireland beBeeQuality Full time

Quality Assurance Professional

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with SOPs, GMPs and applicable regulations.

Key Responsibilities:

  • Conduct auditing/review of batch documentation to ensure adherence to regulatory requirements.
  • Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods.
  • Communicate effectively with functional areas to develop strong working relationships.
  • Manage product recalls and stock recoveries as necessary.
  • Identify compliance gaps and recommend continuous improvement opportunities.
  • Create and maintain assigned Standard Operating Procedures (SOPs).
  • Perform and review complaints and deviation investigations, change controls and CAPAs.
  • Assist in the induction process for new starters and training of other staff members.
  • Compile data for reports and presentations, provide data interpretation and draw conclusions.
  • Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
  • Stay up-to-date with cGMP requirements as described in applicable worldwide regulations.
  • Represent the department on cross-functional teams.
  • Assist in the generation, review and approval of Technical & Quality Agreements.

Requirements:

  • Bachelor degree in a Quality, Science or Engineering discipline.
  • 3 years of relevant post-degree experience in a GMP environment.

Benefits:

  • Opportunity to work with an award-winning Pharmaceutical organization.
  • Excellent position for those looking to join a leading multinational company.

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