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QA Specialist - Technical Support - General (QA TS), Dublin South
Location: Dublin South, Ireland
Job Category:
EU work permit required: Yes
Job Reference: 5084331_1735911067
Job Views: 25
Posted: 03.01.2025
Expiry Date: 17.02.2025
Job Description:
Global Biotechnology company, based in south Dublin, Ireland – looking for QA Specialist - Technical Support (QA TS). This would be a 12+ months contract opportunity with possible extension. The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.
The Job:
1. Provide overall quality direction and oversight into key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Automation & Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and company expectations.
2. Quality review and approval of Validation documentation and SOP's to support site validation activities.
3. Review of DS & QRAES documents.
4. Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents.
5. Review of executed validation documents and reports.
6. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
7. Provide Quality direction and input at Change Control and Deviation Review Boards.
Have You:
1. University degree. Science or engineering related discipline is preferred.
2. Relevant experience (5 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Information Systems).
3. Understanding of principles of Validation and New Product Introduction.
4. Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
5. Ability to work independently and remotely with minimum direct supervision.
6. Strong organizational, communication, coordination, and meeting facilitation skills.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; 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 telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to [emailprotected].
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