QA Validation Specialist – Equipment, Utilities, 6 mth contract
QA Validation
Specialist – Equipment, Utilities, 6 mth contract
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 and approve qualification and requalification protocols
(IQ/OQ/PQ) for equipment, systems, facilities, and plant utilities.
· Support and oversee execution of qualification activities, including
area and drawing walkdowns and vendor interactions (e.g., FAT).
· Review and approve related documents such as User Requirement
Specifications, SOPs, drawings, and support files.
· Provide QA oversight and subject matter expertise on qualification,
validation, and computerized system validation (CSV) activities, including data
integrity compliance.
· Lead investigations into qualification-related deficiencies and drive
corrective and preventive actions.
· Approve calibration, preventive maintenance (PM) activities, and
associated work orders for qualification activities
· Support internal and external audits (e.g., FDA, HPRA) and ensure
ongoing audit readiness.
· Promote continuous improvement initiatives within validation and
contribute to performance KPI reporting.
· Assist with training of QA and validation personnel and maintain
validation documentation and archive systems.
Education
& Experience:
- Bachelor’s degree in Science or Engineering
(or equivalent) with 5+ years of experience in a pharmaceutical QA
validation role.
- Strong understanding of EU and FDA regulations
related to equipment, facility, and computerized system qualification.
- Knowledge of Data Integrity, Good
Documentation Practice (GDP), and validation lifecycle principles.
- Excellent written and verbal communication,
organizational, and interpersonal skills.
- Demonstrated ability in protocol/report
writing, problem solving, and cross-functional collaboration.
- Eligible to work in Ireland.