Quality Assurance Compliance Manager
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| Job Type | Permanent |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2947 |
| Job Views | 838 |
- Description
- Do you possess a high level of expertise in Quality Assurance?
Team Horizon is recruiting for a Quality Compliance Manager on behalf of a multinational leader in the pharmaceutical industry.
This is an exciting opportunity for an innovative thinker and problem solver to join a high achieving team at their manufacturing facility based in Dublin.
Why you should apply:
Join a company whose goal is to help patients live healthier lives and are proud to be a Great Place to Work.
Be part of a diverse and dynamic team where you will have the opportunity to work with experienced leader in a globally recognised biotech company.
What you will be doing:
Responsibility for the delivery and leading the QA aspects of the Quality System including:
· Management Review
· Supplier Program
· CAPA
· Change Control and Documentation
· Complaints
· Training
· Inspection Readiness & Management
· Internal Audit
· Quality & Technical Agreements
· Continuous Improvement and Simplification Initiatives
Developing and managing a Quality System, ensuring compliance by all departments and personnel
Preparation and maintenance of Site Master File, Quality Manual and Quality Plans
Ensuring that products manufactured meet requirements of end users, Regulatory Authorities and of the company.
Developing and maintaining performance measurements of the quality system and reporting on this at the management review meeting and during quality performance meetings.
Act as Designee for Associate Director QA Compliance as required.
Adheres to and supports all EHS standards, procedures and policies.
Works directly with the Quality Operations Manager to support day to day site activities
Expertise in Assessing Quality Issues: A high level of expertise is required to assess day-to-day quality issues effectivel, utilising knowledge and understanding of quality standards, processes, and regulations.
Innovative Thinking and Problem Solving: The role requires innovative thinking, where new and untested solutions are proposed, demonstrated, and implemented regularly·
Lead, manage and develop a team of professionals and direct reports within the QA compliance group as assigned
Responsible for setting annual goals, completing reviews, growth plans and performance management of the team
Quality risk managment (within the team) , support / approve LIRS, develop and roll out metrics and support PQR.
What you need to apply:
Third level qualification in a science discipline with 8 years’ experience in the healthcare / pharmaceutical industry.
Degree or Masters level.
Being QP eligible is desirable. ·
8 years industrial experience gained in an FDA and EMA approved pharmaceutical or device environment.
Minimum 2 years supervisory experience.
Demonstrated Audit/ Inspection Management experience.
Requires total commitment to quality and maintaining a high standard of work at all times.
