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Details

Quality Compliance Specialist


Reference:PORA005748 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

A Quality Compliance Specialist - Change Control is required to join a leading Biopharmaceutical organisation based in Limerick. The focus of the role is to co-ordinate and maintain the site Change Control process to ensure that this key element of the Quality Management System continuously operates in a compliant manner while meeting ongoing business requirements. The role may also involve supporting other quality system elements such as Deviations, CAPA or QRM as required.

Responsibilities

  • Responsible for ensuring compliance with all aspects of Quality for the site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Primarily responsible for administration and oversight of the Change Control process but may also be responsible for one or more of the site quality systems including but not limited to;

- Deviations
- CAPA
- Quality Risk Management



  • Responsible for review and approval of associated change control documents, and other documents such as:

- Failure investigations
- corrective/preventative action documents
- Standard operating procedures



  • Maintaining the electronic systems used for Change Control, Deviation Management and CAPA.
  • Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements
  • Provision of monitoring and trending metrics associated with change control and other site quality systems
  • Participates in regulatory and customer audits.
  • Participates in quality risk assessments.
  • Training of personnel on change control and other quality system processes

The Person



  • Requires BSc/BEng in scientific discipline or related field
  • 3+ years of Quality Compliance experience in pharmaceutical or related industry (GMP required)
  • Proven experience in in quality systems and change control







If you would like further Information you can contact the recruiter directly:



Paula O'Reilly | Tel: +353 (0) 1 507 9265