Senior QA Technical Specialist
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2902 |
| Job Views | 766 |
- Description
- An exciting opening available for an experienced Senior QA Specialist (Technical Support) for our client, who is a leading biopharmaceutical company based in Dublin. In this role you provide quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering
Why you should apply:
Join a progressive forwrad thinking company, with a culture of continuous improvement and innovation
State of the Art working facilities, flexible working conditions, including flex hours and work from home
What you will be doing:
Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory expectations.
Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:
o DS, URS & QRAES documents
o Validation Plans, Protocols, IQ, OQ, PQ and associated documents
o Executed validation documents and reports
Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities
Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records
Quality review/approval of BOMs, MBRs and recipes.
Write, review and approve Standard Operating Procedures
Perform all activities in compliance with business requirements
Any other duties as required
What you need to apply:
University degree. Science or engineering related discipline preferred.
Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall
Experience in NPI/ technology transfer / product lifecycle changes.
Understanding of principles of Validation and New Product Introduction
Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
Ability to operate across functional boundaries, both internal and external.
Ability to work independently and remotely with minimum direct supervision.
Critical thinking skills.
