QA Specialist

Desired Skills: quality assurance,validation,NPI

Description:

PE Global is currently recruiting for a QA Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role.

Overview:

• 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.

Key Responsibilities:

• Provide overall quality direction and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), 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

Education and Experience:

• University degree. Science or Engineering related discipline preferred.
• Understanding of principles of Validation and New Product Introduction
• Experience in aseptic manufacturing
• 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. 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 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, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@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***