Job Summary
:
The Quality Systems Specialist supports the company’s Quality Management System (QMS) through a wide variety of activities, covering document control, eQMS (Agile) administration, data analysis and Key Performance Indicators (KPI) reporting at a department and site level (including Management Review, CAPA Review Board, Materials Review Board), internal / external audit process, progression of quality records and training delivery. The role also supports the Quality Systems Lead in administrating the CAPA, Non-conformance and Internal Audit processes.
Essential Functions & Accountabilities:
1. Expertise in the Document Management processes in the eQMS system including:
2. Act as department point of contact for users of eQMS with document changes, workflow or record issues to ensure compliance and correct usage of the system.
3. Act as department point of contact for Controlled Document Distribution and Periodic Document Review processes.
4. Facilitation of document and training position updates through processing of DCRs into DCOs and verification of DCR/DCOs processed by other team members.
5. Ensuring appropriate cross-references and document hierarchy are maintained within the eQMS system.
6. Developing and delivering training for use of the document management processes in eQMS.
7. Governance of the document management processes
8. Expertise in the eQMS Administration including:
9. Processing of all types of access/privilege requests (Service Desk Tickets).
10. Problem solving or escalation of system issues.
11. Progression of quality record such as QFB, Lot Blocks, SNCs
12. Data gathering, analysis and reporting KPIs related to the use of the eQMS including:
13. Production of reports, scorecards, KPIs, analysis and trend information.
14. Identification and escalation of identified trends.
15. Presentation of departmental End of Month and Material Review Board meetings.
16. Development of appropriate department metrics and improvements to data analysis and reporting processes.
17. Preparation and administration of Management Review (MR) and CAPA Review Boards (CRB)
18. Designated trainer for Documentation management and eQMS processes.Supporting training activities for other QA processes.Coaching and developing QS personnel
19. Leads or participates in multi-disciplinary teams engaged in change management processes, to ensure that the agreed deliverables are achieved. Including:
20. Completing approval of documented changes prior to implementation
21. Supporting the Internal and External Audit processes, including:
22. Leading Internal Audits in accordance with ISO13485.
23. Preparation and participation in External Audits.
24. Assisting in the resolution of audit actions.
25. Support governance of the internal audit programme
26. Supporting the non-conformance and CAPA processes, including:
27. Leading and /or facilitating investigations and root cause analysis.
28. Implementation of corrective and preventative actions.
29. Supporting training for use of NCR/CAPA processes in eQMS.
30. Support governance of the NCR/CAPA processes
31. Perform any other duties identified by QA Management and provide support to all parts of the organisation, as may be required.
Travel Requirements
The role is based at Delta Park, however local travel to Mountpark and / or Hamble may be required.
Knowledge, Skills and Abilities
32. Excellent written and verbal communication skills.
33. Excellent organisational skills and attention to detail.
34. Computer literate, with strong skills in the use of Microsoft Word, Visio, PowerPoint, Excel (including pivot tables and formulas), Outlook and Teams.
35. Excellent interpersonal skills, both in person and virtually.
36. Quick to learn and apply new knowledge and skills.
37. Ability to prioritise workload as appropriate.
38. Able to identify, analyse and solve problems.
39. Able to work effectively either alone or as part of a team.
40. Flexibility to work across the UK Hampshire sites.
41. Full, current driving license.
Experience and Education
42. Minimum of 2-years’ experience of working in a Pharmaceutical/ biotech/ medical device industry.
43. Demonstrated experience of supporting a Quality Management System ., Deviations, CAPA, Change Control.
44. Experience of participation in external audits (such as Regulatory or Client audits).
45. Strong working knowledge of eQMS systems.
46. Good working knowledge of the regulatory expectations for document control, non-conformance / CAPA, internal audits, change management, training.
47. Qualified Internal Auditor.
48. Excellent understanding of the principles and guidelines of cGMP.
49. Ideally educated to Degree standard or relevant experience in a medical device, regulatory, or computer systems environment.
What we offer:
You’ll receive competitive compensation and a fantastic benefits package including 25 days holiday, pension scheme, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!
We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop in your career and grow with CooperVision.
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering an inclusive culture is and how different perspectives add value and contribute to our success.