QA Specialist, QA Distribution
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2840 |
| Job Views | 1185 |
- Description
- Team Horizon is seeking a QA Specialist for our Clients QA Distribution team at their manufacturing facility in Dublin. This is a hybrid role with the flexibility to work remotely up to 2 days per week.
Why you should apply:
This is an excellent opportunity to join a growing, progressive and diverse company
Work with a company who are passionate about improving the health and the lives of their patients worldwide
Flexible start & finish times
What you will be doing:
Responsible for Quality oversight of temperature controlled product activities in all markets in accordance with local and international requirements and planning schedules; insure products shipments are managed in accordance with GDP’s requirements
Assess temperature controlled shipments and provides corresponding quality decision on product.
Act as primary Quality technical contact point with distribution partners.
Provide guidance, drive and monitor Quality issues related to temperature controlled products and GDP to resolution within the company and with external parties
Review documentation including change controls, deviations, validation documentation, SOPs and specifications
Ensure Quality Agreement with distribution contractors and carriers are established and maintained.
Support the conduct of Quality and Operations review meeting with Distribution contractors
Contribute to define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to GDP’s contractors
Support the preparation of Health Authorities inspections and provide support for regulatory submissions.
Any other duties as assigned
What you need to apply:
Undergraduate Degree in natural or applied sciences (Pharmacy, Chemistry, Biotechnology, Engineering etc.) required.
4- 5 years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment
Knowledge of temperature-controlled product activities desirable
Thorough knowledge of cGMPs/GDPs and global regulatory requirements
International exposure in positions interacting with and influencing site operations.
Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment.
Good verbal and written communication skills with well-structured communication and ability to present to various audience levels.
Experience leading inspection readiness and supporting various global regulatory/quality inspections.
