QA Specialist

PE Global is currently recruiting for a Senior Quality Assurance Specialist for a leading multi-national Pharma client based in Dun Laoghaire.

This is a contract position.

Role:
• Provide overall quality direction and oversight for 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 Amgen expectations.
• Quality review and approval of Validation documentation and SOPs to support site validation activities:
• Review of DS & QRAES documents
• Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
• Review of executed validation documents and reports
• 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.
• Perform all activities in compliance with Amgen safety standards and SOPs
• 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

Requirements:
• 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 quality direction and oversight for key functional areas (i.e. Packaging, Validation, Quality Control, Engineering, Information Systems)
• 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.
• 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.

Interested candidates should submit an updated CV.
Please click the link below to apply, or alternatively send an up to date CV to audrey.mccarthy@peglobal.net.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***