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Quality Compliance Specialist - Change Control

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 08/08/2018
  • Job reference: BBBH15274


Quality Compliance Specialist

A Quality Compliance Specialist - Change Control is required to join a leading Biopharmaceutical company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.

This role will be responsible for co-ordinating and maintaining 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. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical industry.

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
  • Actively participate in continuous improvement initiatives
  • Participates in regulatory and customer audits
  • Collaborates with functional departments to resolve issues and maintain compliance
  • Identify gaps in systems and develop feasible plans for correction
  • Training of personnel on change control and other quality system processes



Education/Experience

  • Requires BSc/BEng in scientific discipline or related field
  • 3+ years of relevant work experience in pharmaceutical or related industry



Interested?
Do not hesitate to reach out to Jack on 01-6455250 or send your CV to jack.conway-kenny AT experis.ie

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