QA Manager
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| Job Type | Contractor |
| Location | Dublin |
| Area | Dublin |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002681 |
| Job Views | 207 |
- Description
- Team Horizon is seeking a QA Manager (6-month contract) to be part of our client’s team who are a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader.
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.
Excellent career progression opportunities.
What you will be doing:
The Quality Manager (Auditor) has key responsibilities in the management of the GMP, GDP and Medical Device internal and supplier audit programs. Managing the initiation, assignment, execution and close-out of all audit observations and related response actions.
Maintaining an up-to-date global audit schedule and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership.
Contributing to the further development of the audit function by shaping the Alexion audit landscape through proposals and innovative solutions.
Developing solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought and analysis.
Driving, role modeling and supporting a strong lean culture that promotes standardization, simplification and continuous improvement.
Maintaining an up-to-date global audit schedule and generating periodic metric reports suitable for viewing by and presentation to Senior Management/leadership.
What you need to apply:
A minimum of 7-10 years relevant experience within the pharma industry or a related field.
QP Qualified is desirable.
Strong knowledge of cGMP requirements for pharmaceutical manufacturing required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
Excellent accuracy and attention to detail
Good knowledge of relevant computer packages e.g. Trackwise or similar
Planning and organizing skills are required to plan, execute, and track commitments of Quality Assurance and to adjust to changing priorities.
High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management. Technical writing skills required.
3-5 years’ experience in a QA environment in a leadership role.
Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
