Exciting new opportunity for a Quality Compliance/Systems Specialist in Limerick.
This is a permanent role with a top multinational in Limerick.
The Quality Compliance/Systems Specialist will co-ordinate and maintain the sites 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. You may also be involved with supporting other quality system elements such as Deviations, CAPA or QRM as required.
Role of this position
- 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.
- Participates in quality risk assessments.
- Collaborates with functional departments to resolve issues and maintain compliance.
- Requires BSc/BEng in scientific discipline or related field.
- 3+ years relevant work experience in pharmaceutical or related industry.
Please call Michelle Galvin today for further information on 091 373 938 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)