Quality Auditor

3 weeks ago

Cork, Cork, Ireland Orion Group Full time

Orion Group Life Sciences is currently recruiting a Quality Auditor on behalf of our multinational biopharmaceutical client based in Tipperary. This is an initial 11-month contract with potential for extension.

Role Functions:

The incumbent will ensure the timely and effective completion of the Quality Systems core functions in accordance with schedules, policies, procedures, and guidelines, including:

  • Quality SME for Process, Cleaning, Water, Equipment
  • Provide leadership regarding validation standards for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
  • Participate in and support site validation committees such as PVC, WVC, CVG, and EQVC.
  • Approve validation documentation and ensure compliance with policies and guidelines, maintaining validation status after changes.
  • Support site or capital projects by defining validation requirements and offering technical support.
  • Develop Validation Summary Reports and assist in creating overall Quality plans for major projects.
  • Collaborate with other industry and company areas to anticipate validation trends and best practices.
  • SAP Quality Process Steward.
Additional Responsibilities:
  • Change Control SME: Serve as the principal quality contact for site change requests and material control strategies.
  • Laboratory QA oversight: Support and approve laboratory systems, instrumentation, investigations, and stability reports.
  • Microbiology: Liaise with microbiologists on microbial issues related to water, utilities, environment, and products.
  • Quality Agreement System Management: Manage Quality Agreements for all relevant relationships.
  • Annual Review System Management: Ensure completion of Annual Reviews for products and systems.
  • Documentation: Create, review, and approve site quality documentation including the Site Master File and Validation Master Plan.
  • Quality Council: Manage schedules, agendas, minutes, and actions.
  • Supplier and Customer Complaints: Participate in investigations and reviews.
  • Regulatory and Filing Support: Maintain licenses, support product filings, and review regulatory documentation.
  • Returned Goods and Audit Program: Manage segregation/disposition of returned goods and support audit activities.
Experience, Knowledge & Skills:

Technical expertise in engineering standards, plant procedures, equipment, validation principles, and system development lifecycle. Proficiency in computer applications, report writing, problem-solving, and continuous improvement are essential.

Qualifications & Education:
  • Minimum degree or postgraduate qualification in Science, Pharmacy, or Engineering.
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