Qa Specialist - Ptqa

Overview

Global Biotechnology company, based in south Dublin, Ireland – looking for

Quality Assurance Specialist

The successful candidate will be 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 company and regulatory expectations.

Responsibilities

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.

Perform all activities in compliance with company safety standards and SOPs.

Qualifications

University degree - preferred science or engineering related discipline.

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)

Understanding of principles of Validation and New Product Introduction.

Experience in aseptic 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.

Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.

Team players are prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

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

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

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