Job Description:
Global Biotechnology company, based in Dublin, IRL – looking for Quality Assurance Specialist (Senior) – Technical QA.
Senior QA - professional will provide quality direction and oversight for activities related to the installation of new syringe and inspection lines and products at our facility in Dublin.
This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C&Q / Validation and Technical Transfer requirements.
The role:
* Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation.
* Act as the Quality point of contact and decision - maker for C&Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
* Lead Quality review and approval of validation documentation associated with new facilities and new product introduction.
* Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable.
* Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements.
* Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations.
* Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas.
* Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction.
* Provide input and Quality Oversight for change control development and implementation.
Have You:
* University degree in a Science-related discipline.
* Minimum of 7+ year's relevant experience 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).
* In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.
* Experience working in aseptic operations, relating to vial and syringe filling.
* Understanding of principles of Validation and New Product Introduction.
* Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions).
* Strong organizational skills with the ability to manage tasks through to completion.
* Ability to work independently and remotely with minimum direct supervision.
* Strong critical thinking and problem-solving abilities.
* 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.
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 akremenskas@berkley-group.com
