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Quality Assurance Specialist (Senior)

  • Job reference: 921980
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 03/10/2018

The Orion Group are seeking a Senior Quality Assurance Specialist to work with our multinational biopharmaceutical client in Dublin

The QA Specialist will typically report to a QA Senior Manager and will be required to be a Subject Matter Expert in the Incoming Quality Assurance Area (IQA)

Some of the role duties will include:

  • Participation in self-inspection program in a lead auditor or auditor capacity.
  • Quality Risk Management execution/facilitation
  • Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as
  • Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums.
  • Provide Subject Matter Expert for quality critical components.
  • Approve QA Incoming results.
  • Provision of Quality Oversight and partnership for internal and external customers
  • Plan and perform routine analyses with efficiency and accuracy.
  • Plan and perform multiple, complex routine/non-routine methods and procedures.
  • Write protocols and perform validation and equipment qualification/ verification.
  • Introduce new techniques to QA Incoming, including method transfers, reports, validations and protocols, which includes management of change controls.

Relevant Experience:

  • University degree. Engineering or Science related discipline preferred.
  • Relevant experience (8yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

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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