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Senior QA Specialist

  • Job reference: 927903
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 26/09/2019

Orion Group are looking for a Senior QA Specialist for our multinational pharmaceutical client based in the South of Dublin 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

  • Accountable for Quality oversight of processes and procedures related to IS, CS & Automation compliance
  • Quality review and approval of Validation documentation and SOPs as they apply to IS, CS & Automation projects
  • Review of DS & QRAES documents
  • Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
  • Review of executed validation documents and reports
  • Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures
  • 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

Desired Experience and Background of the successful candidate

  • University degree. Science or Engineering related discipline preferred
  • Relevant experience (5yrs +) working in the Medical Device, pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role
  • Understanding of Information Systems, principles of Automation and system architectures
  • Experience in cGMP regulated environments and knowledge regarding FDA cGxP and 21 CFR Part 11 regulations and an understanding software system validation is required and working knowledge of the GAMP software development lifecycle
  • 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

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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