Job Description
Position
Quality Assurance Specialist
Department
Quality Assurance
Immediate Supervisor
Quality Assurance Assistant Manager (or designee in their absence)
Top 3 things to know about this job
1. Progressive company
2. Positive working environment and culture.
3. Job security along with continuous training and development
Job Outline
Duties
4. Maintenance of the Quality Management System (QMS) and the use of its associated software (Pragma and Adhoc)
5. Review of manufacturing and cleaning records
6. Review of shipment documentation and containers prior to release
7. Issuance of materials to production
8. Performance of the Good Manufacturing Practice (GMP) Walkthroughs as scheduled
9. Provision of proactive reporting, investigation and response to quality related issues
10. Liaison with the Quality Assurance Assistant Manager on matters such as those related to the QMS, audits, documentation, etc
11. Preparation of quality documentation such as product quality reviews
12. Performance of cleaning visual inspections
13. Provision of training to others as required
14. Provision of assistance with audit preparation and the performance of internal audits as required
15. Provision support to other departments for quality related issues and to the Quality Assurance Assistant Manager to ensure site adherence to current GMP
16. Perform other duties as assigned by their supervisor (or designee in their absence)
Responsibilities
17. To adhere to cGMP and EHS practices at all times
18. To liaise with supervisors to ensure the rapid communication of issues and the progression of projects, material release, etc.
19. To ensure the QMS is maintained as per cGMP including but not limited to change controls, deviations, corrective and preventative actions, controlled documentation, etc.
20. To prepare quality documentation including but not limited to product quality reviews, quality risk assessments, etc. To critically review and approve updated documentation as required
21. To critically review manufacturing, cleaning and shipment documentation to ensure their adherence to cGlv1P and to address any outstanding issue prior to release
22. To ensure that all material meets the relevant requirements, and all issues are resolved prior to approval and release
23. To support the Quality Assurance Assistant Manager with audit preparation and to participate in audits To assist other department members issues as required
24. To assist with periodic reviews of the QMS and its communication to site management and the Corporate Quality
Assurance and Regulatory Affairs Director
25. To have a general interest in quality assurance activities and the desire for improvement opportunities
JOB DESCRIPTION
26. To act as a designee for the Quality Assurance Assistant Manager in their absence if no Quality Assurance Supervisor is present
Working Conditions
This position is primarily an office-based role in the Quality Assurance with some duties performed within the GVW areas such as production, quality control and the warehouses
The company will provide workplace conditions in which its personnel can function safely and efficiently. All personnel are required to comply with current standard operating procedures and cGMP as required.
Work Performance
The employee's performance will be monitored by the Quality Assurance Assistant Manager and will be assessed as per the following criteria:
27. General timekeeping and attendance
28. Work output
29. Quality of workmanship
30. Compliance with agreed work schedule and programme
31. Compliance with Health, Safety and Environmental and Quality practices
32. Ability to work in a team environment
33. Ability to work independently
34. Work attitude
35. Training and self-development
36. Contribution to improving the department
37. Overall team performance
Next Steps
Click apply to start the process today or reach out to Conor O'Hagan at Hunter Savage for further information