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Quality Assurance Specialist

  • Job reference: 926960
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 07/08/2019

Hello all. I am currently seeking a Quality Assurance Specialist for an initial 12-month contract with our client in the South of Dublin. Please contact me at Andreia.Terron@orioneng.com for more details

Quality Assurance Specialist

Description: 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. QA TS Specialist will be required to understand and grasp a broad range of quality related competencies.

In addition to routine Quality Assurance duties, QA TS Specialist may be assigned specific oversight and responsibilities for key quality systems or processes and may also serve as a primary quality partner/point of contact for products or functional areas within the company, including Supply Chain, Information Systems, Manufacturing, Process Development, Validation, Engineering and Quality Control. QA TS Specialist may be cross trained and/or assigned additional project specific duties, including continuous improvement/operational excellence initiatives.

Primarily responsible for Quality Assurance Specialist activities, which may include any/all of the following:

  • 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.
  • 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.
  • Review and approve validation lifecycle documents, including Master-plans, protocols, reports and active participation during earlier phases of process design, Characterisation, Commissioning etc.
  • 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.
  • Review and approval of Master Batch Records and SAP BOMS
  • Quality SME reviewers/approvers for regulatory submissions, ensuring compliance with site and corporate procedures.
  • Perform all activities in compliance with client 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

Basic Qualifications:

  • University degree. Engineering or Science related discipline preferred
  • Relevant experience (5yrs +) working in the pharmaceutical or biotechnology industry ideally, however candidates from clinical, med device would be consideration but they would need to have aptitude, be self-motivated with a QA or validation background
  • Experience working with dynamic cross-functional teams and proven abilities in problem solving and decision making
  • Experience working in aseptic operations, protein formulation, vial and syringe filling
  • Experience working in QA Technical Support or validation functions, including experience of New Product Introductions, Technology Transfer and Process Validation activities
  • Detailed Knowledge of applicable Regulatory requirements and experience with Regulatory inspections
  • Excellent written and verbal communication skills
  • Strong organizational skills, including ability to follow assignments through to completion

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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