This position is no longer open for applications
QA Validation/Technical Support Specialist
12 month contract with potential extension. A Technical Specialist supporting equipment qualification and validation activities across packaging, engineering, and utilities. Acting as QA SME for validation documentation, reviewing protocols and qualification reports, and providing QA oversight on technical projects.
Responsibilities
Accountable for quality oversight of processes and procedures related to packaging, inspection, process development, validation, engineering, facilities/utilities.
Quality review and approval of validation and qualification documentation and SOPs to support site validation activities:
Review of DS & QRAES documents.
Review of validation plans, protocols, IOQs, PQs and associated validation documents.
Review of executed validation documents and reports.
Perform all activities in compliance with Amgen 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.
Qualifications
University degree. Science or Engineering related discipline preferred.
Relevant experience (7+ years) working in the pharmaceutical or biotechnology industry as a subject matter expert providing quality direction of introduction of automation/IS projects.
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.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com.
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on +353 86 126 3871 or send your CV to doconnell@berkley-group.com.
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