Exciting new opportunity for a Senior Quality Compliance Specialist with 4+ years' experience in Limerick.
The successful candidate will maintain site compliance of operations inclusive of but not limited to Manufacturing, Quality Systems, Quality Control, Quality Assurance, Facilities Maintenance, Materials Handling, and QA Validation in accordance with mandated regulatory requirements and site expectations.
Role of this position
- Responsible for ensuring compliance with all aspects of Quality for the Limerick site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
- Administration and oversight of site quality systems including but not limited to; Deviations, CAPA, Change Control, Audits, Customer Complaints, Quality Risk Management.
- Responsible for review and approval of the following types of documents, relating to area functions: failure investigations, change control documents, corrective/preventative action documents, standard operating procedures.
- Maintaining electronic systems used for Change Control and Deviation Management.
- 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 site quality systems.
- Participates in regulatory and customer audits and quality risk assessments.
- Requires BSc/BEng in scientific discipline or related field.
- 4+ years of relevant work experience in a pharmaceutical or related industry.
- Supervisory experience advantageous.
- Good working knowledge of electronic Quality Management Systems and associated metric generation preferred.
Please call Michelle Galvin today for further information on 091 373 938 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)