QUALITY COMPLIANCE SPECIALIST required by a top company in Limerick. The Quality Compliance Specialist 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. Excellent role for a strong driven candidate with 2+ years' relevant experience.
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.
- 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.
- 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 quality system processes.
- BS/BA in scientific discipline or related field.
- 2+ years of relevant work experience in pharmaceutical or related industry. Relevant experience may be substituted for education requirement.
Please contact Michelle Galvin on (091 373 938) email@example.com for further information on this exciting opportunity.
CareerWise Recruitment (In Search of Excellence)