Global Biotechnology company, based in Dublin, Ireland - looking for
Senior Quality Assurance specialist.
The
Plant Technical Quality Assurance
(PTQA)
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:
* Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities for Aseptic products, ensuring that all activities meet Amgen and regulatory expectations.
* Quality review and approval of Process Development and Validation documentation:
* Technical transfer documents
* Validation Protocols, executed validation documents and reports
* 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.
Have You:
* University degree. Science or engineering related discipline is preferred.
* Understanding of principles of Validation and New Product Introduction.
* Experience in aseptic manufacturing
* Relevant experience (8 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. Process Development, Validation, Manufacturing)
* 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.
* Strong organizational, communication, coordination, and meeting facilitation skills.
Preferred experience:
* Proven expertise in facility startup and Quality Oversight of Operational Readiness and technology transfer activities.
* In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections including EU/FDA GMP, Annex 1, and process validation life-cycle requirements.
* Experience working in aseptic operations, relating to vial and syringe filling.
* Experience managing change control, deviations, and CAPAs through electronic QMS systems (e.g., Track Wise, Veeva Vault, PAS-X, SAP).
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-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone
Aleksas Kremenskas
at
or send your profile to
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