QA Validation Specialist (HVAC & Utilities)
Industry : Pharmaceutical
Hybrid working permitted (3 days on-site & 2 days remote per week), however depending on project execution, there may also be times when the QA Validation Specialist is needed on site for full weeks also. All reviews of executed protocols would be on site.
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. Support to production / engineering to ensure the qualified state of equipment, systems, facilities and utilities are maintained.
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 execution of Qualification / Re-Qualification and Validation activity
- Generates and executes project validation plans and validation master plans.
- Co-ordinates with manufacturing / engineering personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
- Investigates any deficiencies related with qualification activities and determines corrective actions.
- Preparation and review of SOPs and Drawings as related to validation.
- Review and approval of calibration and PM activities (e.g. schedules) and Work orders.
- Preparation, execution and support of studies / risk assessments / investigations related to Qualification.
- Participates in any investigations that may impact the qualified state of equipment, systems, facilities or utilities.
Location: Cashel, Co. Tipperary
Duration: 6 – 12 month contract