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Rachel Kent
Life Science

+353 87 427 8808
[email protected]
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Details

Quality Auditor (Systems Specialist)


Reference:RK22464 Location: Tipperary
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Auditor

Quality Auditor (Systems Specialist)
RK22464
Contract – 11 months
Tipperary

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties:

• Complete sub system ownership responsibilities as per the site System Ownership list.
• Quality SME for Process, Cleaning, Water, Equipment
• Quality SME for Change Control.
• Support and approve the systems supporting laboratory functions, instrumentation and GLIMS. Provide Quality oversight and approval for laboratory incidents / investigations and documentation.
• Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate).
• Microbiology Point of Contact. Knowledge of microbial requirements in the pharmaceutical industry, to liaise with site Microbiologist for all microbial issues eg water, utilities, environment, excipient or product and as necessary.
• Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. Interact and communicate with SD&PM, relevant stakeholders and external parties to ensure appropriate Quality Agreements are current, approved, on file and retrievable.
• Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems incl automation, are completed to meet the Annual Review schedule.
• Creation, review and approval of Site Quality documentation (Site Master File, Validation Master Plan, policies or procedures)
• Quality Oversight of site application User Access Reviews
• Review and approve Supplier Change Evaluation documentation.
• Supplier and Customer complaints
• Support the internal GMP walk-down and scheduled audits program.


Experience and Education:


• Degree or post-graduate qualification in Science, Pharmacy or Engineering field
• 3+ years’ experience, ideally in Quality within the Biological and/or pharmaceutical industry.
• Laboratory Quality Systems and Quality SME experience


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.