Quality Systems Controller (Pharma)

ICDS Recruitment

Waterford

Quality Systems Controller - Waterford. Job Purpose: 1. Maintain control over training records, master documents and documentation vault. 2. Quality Systems documentation controller. 3. Ensure all activities are carried out in compliance with regulatory and internal customer requirements. Key Responsibilities: 1. Electronic Documentation Management System - QUMAS. a. Check own work and that of others for accuracy during generation and reviewing of documentation. 2. Control of inventory and access to Documentation Vault. 3. Maintenance of documentation 5S standards. 4. Maintenance of company training database. 5. Management of personnel training folders. 6. Management of Master Batch Documentation. 7. Preparation and management of documentation archival and documentation retrieval. 8. Scanning / Filing of Quality Systems documentation. 9. Printing and preparation of hard-copy documentation for manufacturing / Laboratory to include Batch Manufacturing Records and logbooks. 10. Maintenance of QS indexes (management tools. 11. Issuing numbers from controlled QS indexes. 12. To assist in the preparation for customer / regulatory inspections to ensure efficient and accurate document retrieval. 13. To ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLP, SOP’s, regulatory regulations and guidelines, safety and environmental guidelines. Minimum Qualifications & Experience sought: At least two years administration experience. Strong attention to detail. Working knowledge of Word / Excel. This job originally appeared on RecruitIreland.com.

2233 days ago