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QA Specialist

  • Job reference: 930011
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 14/02/2020

Orion Group Life Sciences are looking for a QA Specialist for our Multinational Pharmaceutical client based in the South of Dublin area on an initial 12-month contract with the potential to extend.


Job Purpose

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

Main Responsibilities of the role

  • Quality Assurance Tech Support Team responsible for:
    1) NPI - Lifestyle management changes: New product into the site team support throughout the lifecycle. Engineering, PPQs to filing.
    2) Provide support for bigger projects significant site project changes to the manufacturing areas, cleaning validation, validation supporting automation
    3) IS upgrades, involved with this PSC, MES system get involved through validation of these activities
    4) provide QC team, utility, new fridge freezer equipment etc.
  • Provide overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client 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
  • Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet client and regulatory expectations.
  • 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.
  • Write, review and approve Standard Operating Procedures in accordance with client policies.
  • Perform all activities in compliance with client safety standards and SOPs



Desired Experience and Background of the successful candidate

  • University degree. Science or Engineering related discipline preferred.
  • Relevant experience (5yrs +) 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, Quality Control, Supply Chain, 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.


#pharmaceutical #pharma #multinational #product #biotechnology #NPI #validation #quality #qualityassurance

For more information on this role, call Kate O' Sullivan on +353 (0) 212063412 or email Kate.OSullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930011


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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