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QA Specialist Quality Systems

  • Job reference: 921675
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 14/09/2018

Orion Group are recruiting a QA Specialist Quality Systems for a 12 month contract on behalf of our Multnational BioPharma Client located in Dublin

QA Specialists may be assigned specific oversight & responsibilities for key QA Specialist Quality Systems & Compliance

The QA Specialist is a senior & active role within the broader QA function. The QA Specialist will typically report to a QA Senior Manager & will be required to be a Subject Matter Expert in their assigned area of responsibility. QA specialists will be required to understand & grasp a broad range of quality related competencies. In addition to routine QA duties quality systems or processes and may also serve as a primary quality partner/point of contact for functional areas within the company, including Supply Chain, IS, Manufacturing, Process Development, Validation, Engineering and QC. QA Specialists may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

Basic Qualifications:

* 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.

Preferred Qualifications:

Preferred Qualifications

* Excellent written and verbal communication skills

* Experience working with dynamic cross-functional teams and proven abilities in decision making

* Strong organizational skills, including ability to follow assignments through to completion

* Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations

* Detailed Knowledge of applicable Regulatory requirements.

Experience with Regulatory inspections.

* Experience working in aseptic operations, protein formulation, vial and syringe filling.

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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