Role: QA Validation Specialist
Location: Cashel, Tipperary, Ireland
Type: Permanent/Contract
Role is mostly on-site – could be scope for a small amount of remote, but most weeks would be fully on-site, especially during execution and review of protocols.
Summary: QA Validation role to ensure Qualification of Equipment / Computerised Systems / Facilities and Utilities is performed in compliance with regulatory requirements, company policy, and procedures.
Essential Duties and Responsibilities include, but are not limited to, the following:
Review of Qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant utilities as QA Validation.
Support the execution of Qualification / Re-Qualification and Validation activity
Review and approval of Project validation plans.
Co-ordinates with manufacturing/engineering personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
Investigates any deficiencies related to qualification activities and determine corrective actions.
Review of SOPs and Drawings as related to validation.
Review and approval of calibration and PM activities (e.g., schedules) and Work orders as related to validation.
Review and approval of studies/risk assessments/investigations related to Qualification
Participates in any investigations that may impact the qualified state of equipment, systems, facilities, or utilities
Education & Experience:
Science Graduate with minimum 5 years of experience in the Pharmaceutical Industry, accredited by HPRA and FDA