QA Automation Specialist
This vacancy has now expired
The Quality Assurance Automation Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
Vial Fill line project: New Vial filling line including vial washer, depyrogenation tunnel, filtration skid, Fill line, capper, Isolator, new clean room suite and associated upgrades / tie-ins to clean utilities
- Provide QA support and oversight for IS / Automation validation activities associated with the above ‘Vial fill line project’
- Quality review and approval of IS / Automation documentation
- Review of URS, DS, FS & QRAES documents
- Review of validation Plans, Protocols, SAT, IQ, OQ, PQ and associated validation documents
- Review of executed validation documents and reports
- Perform all activities in compliance with company safety standards and SOPs
- Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
- Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new Fill line / Isolator
- Understanding of Information Systems, principles of Automation and system architectures.
- Experience in cGMP regulated environments and knowledge regarding FDA cGxP and 21 CFR Part 11 regulations and an understanding software system validation is required and working knowledge of the GAMP software development lifecycle
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
- Strong organisational, communication, coordination, and meeting facilitation skills.
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
- Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
If this role interests you, please apply today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
Project Engineer - 12-18 month contract - Dublin The ideal candidate must have an in-depth technical knowledge of the processes to manufacture biologics on a fill/finish site. The expertise that
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