CQV Engineer – QA Validation Department

QA Validation Specialist (CW) – QA Validation Department

Industry : Pharmaceutical

Role Summary:

Schedule, execute and review Continuing Qualification activities for large and small equipment in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures.

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

• Strong Quality background and familiar with Site change controls in general.
• Assess executed change controls and deviations for impact to the Qualified state for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
• Schedule, execute and review Continuing Qualification activities for large and small equipment.
• Implements parent company continuing qualification program for initial qualification of manufacturing equipment and or supporting utilities, at the Limerick bulk biologics facility.

Document preparation for:

• Equipment Qualification Assessments (EQAs).
• Installation Qualifications (IQs), Operational Qualifications (OQs), and where applicable Performance Qualifications (PQs).
  o Summary Reports (SRs), Trace Matrices (TMs)
• 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.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Collaborates with functional departments to resolve issues.
• Excellent communication skills is a must.

Education and Experience:

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