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QA Specialist 30526

  • Job reference: 934339
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 03/03/2021

Orion Group Life Sciences are looking for a QA Specialist for our Multinational Biotechnology client based in the South of Dublin area on an initial 8-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

  • 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 the Client's expectations.
  • Quality review and approval of Process Development and Validation documentation
  • 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 the 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 Review Board 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 the Client's Policies.
  • Perform all activities in compliance with the Client's 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

Desired Experience and Background of the successful candidate

  • University degree. Science or Engineering related discipline preferred.
  • Understanding of principles of Validation and New Product Introduction
  • 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)
  • 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.


#pharmaceutical #pharma #multinational #Techsupport #biotechnology #quality #qualityassurance

For more information on this role, call Ian Towler on +353 (0) 212063411 or email ian.towler@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 934339


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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