Overview
QA Validation Specialist role at Cpl.
Location: Cashel, Co. Tipperary
Reports to: Senior Manager, QA Operations
Type: Full-time, Permanent
Responsibilities
* Review and approve Qualification and Requalification protocols (IQ, OQ, PQ) for equipment, systems, facilities, and utilities.
* Review and contribute to User Requirement Specifications.
* Support the execution of qualification and requalification activities, including walkdowns of drawings and areas.
* Liaise with vendors where required, including participation in FATs.
* Review and approve drawings, SOPs, and supporting documentation.
* Coordinate communication with production and engineering to ensure timely completion of validation tasks.
* Provide QA oversight and regulatory advice on qualification, including CSV and data integrity.
* Support qualification of laboratory equipment, reviewing and approving protocols and reports.
* Lead investigations into qualification-related deficiencies and implement corrective actions.
* Generate and execute project validation plans and master validation plans.
* Prepare and review policies and SOPs related to validation.
* Review and approve calibration and preventive maintenance schedules and work orders.
* Track and manage the annual validation and periodic requalification schedules.
* Support risk assessments, studies, and investigations related to qualification.
* Participate in internal and external audits (HPRA, FDA) and maintain audit readiness.
* Promote continuous improvement in validation systems and manage KPIs for management review.
* Support internal self-inspections and maintain validation documentation and archives.
* Provide training and support to new and existing staff.
* Ensure all work is performed in line with procedural and timeline requirements.
Requirements
* Bachelor’s degree in Science or Engineering.
* Minimum 5 years’ experience in a QA Validation role within the pharmaceutical or biopharma industry.
* Strong knowledge of EU and FDA regulations on Qualification, Validation, and Computerised Systems.
* Understanding of Data Integrity and Good Documentation Practice (GDP).
* Excellent protocol and report writing skills.
* Strong communication, organisational, and problem-solving ability.
* Capable of managing workload and meeting deadlines independently.
* Must be eligible to work in Ireland
Apply: Contact Darren Brown — [email protected]
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance, Science, and Product Management
Industries
* Pharmaceutical Manufacturing
* Biotechnology Research
* Operations Consulting
#J-18808-Ljbffr