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