QC & Stability Compliance Specialist

ICDS Recruitment

Waterford

QC & Stability Compliance Specialist - County Waterford. Job Purpose: To support QC and Stability by ensuring all compliance related issues within the department are fully supported and to communicate compliance updates as required. Key Responsibilities: 1. Progression of QC & Stability Investigations in conjunction with Team Leads, Manager and Quality Assurance. 2. Review the trends from QC & Stability deviations and propose effective preventative actions / training requirements. 3. Generate reports for the QC & Stability department as required e.g. Out of specifications trends, Water Trend Analysis. 4. Pharmacopeia reviews – perform as per schedule and ensure required updates are implemented and communicated to all relevant personnel (internal and external. 5. Liaise with QA Compliance Department for APR’s / PQR’s and assist in the compilation of these when required. 6. Assist in the progression of CACI’s and long term actions. 7. Review training metrics for compliance. Assist in new Learning Management System implementation and maintenance from laboratory updates when required. 8. Progression / monitoring of change control actions required for laboratory to complete or any impacting the laboratory. 9. Assist with Regulatory requests e.g. updating of documents following deficiency responses. 10. Assist with introduction of reduced testing of raw materials where required. 11. To support all other on-going laboratory functions for compliance requirements. 12. To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines. 13. To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. 14. Check own work and that of others for accuracy. 15. To assist in the preparation for internal / customer/ regulatory inspections. 16. Draft, review or revise documentation within documentation management system. 17. Health & Safety. Minimum Qualifications & Experience sought: A relevant qualification in Analytical Chemistry, Pharmaceutical science or related discipline. At least five years' experience working in a regulated environment, with a proven track history of report writing and in the progression of deviations, CACI’s etc. This job originally appeared on RecruitIreland.com.

2054 days ago