QA Compliance Specialist
This job does not exist anymore.
Try running a new searchor browse our vacancies.
Or fill in the form below to receive job alerts.
| Job Type | Permanent |
| Location | Sligo |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Job Ref | 2336 |
| Job Views | 194 |
- Description
- QA Compliance Specialist – Team Horizon
We are currently recruiting a QA Compliance Specialist for our client’s site in Sligo. The Compliance Specialist-QA will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and site requirements, while assessing and reporting on the effectiveness of the quality system to senior management.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will bedoing:
Coordinating the quality system, ensuring full compliance by all personnel with its requirements.
Coordination of Product Quality Reviews activities.
Management of all Technical Agreements from initiation, review, approval and storage.
Coordination and Management of all Track and Trend activities to support Manufacturing and QC.
Driving a QRM approach to all activities on site and coordination and facilitation of all Site RCS and FMEA activities.
Auditing the quality system per the documented internal audit schedule while assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary.
Ensuring that products manufactured at Abbvie Biologics Ballytivnan meet requirements of end users, of regulatory authorities and of the company.
Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings.
Coordinating change management, change control and Change planning activities and monitoring quality performance and advising management personnel on major quality issues.
Liaison with AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies.
Regulatory review
Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required.
Establishing Corrective / Preventive Action system and procedures.
Management of the Supplier program including the ASL, Performance metrics and Audit Schedules
Performance of Vendor audits as required while supporting all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books
What you need to apply:
A 3rd level degree in a science, quality or engineering discipline with 2 + years’ experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical /Biologics/Medical Device)
Masters Degree in Pharmaceuticals with QP Eligibility or recently qualified QP
A strong knowledge of regulatory requirements is required.
Strong communication skills both verbal and written are required for the execution of this role.
Strong interpersonal skills are required.
