Quality Compliance Specialist - Change Control

  • Location

    Limerick, Republic of Ireland

  • Sector:


  • Job type:


  • Salary:


  • Contact:

    Justin Pankinas

  • Contact email:


  • Job ref:


  • Published:

    about 1 year ago

  • Expiry date:


Co-ordinates and maintains 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.

Essential Duties and Responsibilities:
* Responsible for ensuring compliance with all aspects of Quality for the Raheen 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
* 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.
* Participates in quality risk assessments.
* 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 and Experience:
* Requires BSc/BEng in scientific discipline or related field with 3+ years of relevant work experience in pharmaceutical or related industry.
* This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about our Clients unwavering commitment to combining good science & good business.