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Compliance Specialist

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Carlow
  • Sector: Other
  • Date posted: 15/02/2018
  • Job reference: J380496A

Candidates will be responsible for generating and progressing the review and approval processes for documentation associated with GMP (Good Manufacturing Practices) & GDP (Good Distribution Practices) including but not limited to Quality Notifications, CAPAs, Standard Operating Procedures, Work Instructions, Training Curricula, Monthly Financial controls and Change controls within the SCM area.

The successful candidate will ensure that objectives are effectively achieved, consistent with our client's requirements to ensure compliance, safety and reliable supply to their customers.

Principal Accountabilities:

  • Support supply chain activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications.
  • Complete investigation reports and liaise with External Manufacturing, Sending and Receiving sites on investigations related to materials, drug substance and drug product shipments
  • Complete and manage change requests and co-ordination of activities to ensure changes are implemented in compliance with regulatory and quality requirements
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls. Support SCM operations through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the SCM documentation system.
  • Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
  • Assist with Supplier complaint investigations to ensure they are closed out in a timely manner to support site activities in conjunction with cross functional teams as required.
  • Required to comply with company policies, procedures and guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of SCM training if required

Qualifications:

  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline
  • Relevant experience and particular skills in your area of expertise that add value to the business; ideally in a SCM and GMP setting. Skill-sets includes:
  • Proficiency in Microsoft Office and job-related computer applications
  • Knowledge of regulatory/code requirements to Irish, European and international Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Lean Six Sigma Methodology experience desired

If you are interested in learning more, please contact Paul O'Connor on 01 645 5250 or at paul.oconnor@experis.ie