QA Validation Consultant

Recruiters Comments: A leading biotechnology company is currently looking for QA Validation Consultant to join their fantastic team in Limerick!!

This is a 12-month contract and an excellent opportunity to get into a very secure company during this difficult time.

Job Description:

The successful candidate will be working in System Validation activities which includes generation, review & approval of IOPQ protocols and associated validation documents and supervision on execution activities associated with large scale manufacturing equipment

Essential Duties and Responsibilities include, but are not limited to:

• Implements our client continuing qualification program for initial qualification of manufacturing equipment and or supporting utilities
  • This includes document preparation for:
    • Equipment Qualification Assessments (EQAs)
    • Installation Qualifications (IQs), Operational Qualifications (OQs), and where applicable Performance Qualifications (PQs).
    • Summary Reports (SRs), Trace Matrices (TMs)
  • This includes execution for IQ, OQ and where applicable, PQ.
• Based on engineering specification, performs validation projects which include authoring protocols, executing validation protocols and writing reports of validation results.
• Reviews Validation protocols and summary reports generated by the Validation team against standard operating procedures and policies.
• Reviews Change Control test plans generated by the Engineering/Automation/Manufacturing teams against standard operating procedures and policies.
• Responsible for ensuring compliance with all aspects of Quality for the Limerick site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.

Role:

Education and Experience:

• BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 3+ years of related experience within the field

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