Quality Systems Lead
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| Job Type | Fixed Term |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3017 |
| Job Views | 1379 |
- Description
- Team Horizon is seeking a Quality Systems Lead for our Dublin based Client for an 18-month FTC. This is an exciting opportunity to lead a small team where you will have Quality System oversight across two manufacturing facilities.
Why you should apply:
As part of the Quality function, you will benefit from the great facilities and environment the site has to offer. This role will have a lot of visibility and immediate impact with lots of possible opportunities.
Employees are encouraged to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers.
This role is generously compensated and offers career development prospects
What you will be doing:
The Quality Systems Lead Ensures all procedures are controlled and current versions are available to staff as required
Ensures there are no unauthorized changes to documents including creation of local documentation.
Ensures all documentation is relevant and applicable to the process and is reviewed and updated.
Ensures all quality records are reviewed and that they are complete, comprehensive and legible and comply with good documentation practice.
Ensures are quality records are retained in such a way that they remain complete, comprehensive and legible
Responsible for the review and approval of new and updated procedures, controlled documents and processes
Quality System Management and Review; Responsible for the completion of the Quality Management Review meetings and the Annual Product Quality Review
Ensure outcomes, decisions and actions of the review are documented
Ensure meeting actions are completed to agreed deadlines
Report monthly quality KPI to UK/Ireland QA Manager.
Review of quality documentation. QA data review and compilation of reports
Ensure systems are in place to track and trend quality system data and indicators, including but not limited to CAPA and Complaints. Trending should include timeliness in completion as well as actual numbers.
Ensures appropriate Risk identification and management processes are implemented in the compounding unit
Audit Management
Ensuring site-wide local systems are in compliance with Corporate and Regulatory requirements.
Ensures the site has a process for internally reviewing the compliance status and is prepared for an audit at any time
Manages the audit process for the facility, organisation of the management team and staff to ensure a successful audit
Participation in regulatory and corporate / internal audits and performance of supplier audits (as required)
Ensuring that audit findings are fully investigated to find root cause and that actions to address the audit findings are carried out in a timely manner to address the issue
HPRA contact for the Manufacturing Licence and compounding issues
Provide support to the site wide Quality Department
Support compliance to Environmental Health & Safety (EHS) requirements
Compliance to Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP), as applicable
What you need to apply:
Bachelor’s degree in chemistry, Biology or a related scientific discipline.
A minimum of 3 years working within quality in the pharmaceutical industry.
A minimum of 1 years’ experience in a people management role is desirable.
Experience in dealing with Regulatory Compliance desired.
Experience of the following would be beneficial:
Leading Teams • Risk Management • Lean manufacturing experience • Experience of implementing changes and process development.
Computer skills: MS Office, Excel, Visio and Track wise Quality management software would be advantageous.
Good problem solving and investigation skills would be beneficial.
Good professional standards, meticulous and demonstrates good attention to detail.
Ability to work under pressure and meet deadlines.
Highly motivated self- starter and team worker
Ability to work in a team-based environment and ability to manage a wide range of specific tasks Excellent organisational, coordination and communication skills.
Meticulous in attention to professional standards
Good influencing and interpersonal skills
An ability to work in a dynamic, fast-paced and goal driven environment.
