Quality Assurance Senior Specialist (Contract – Dundalk, On-site)
Pay Rate:
€*****/hr – €*****/hr
We are seeking a
QA CSQ/CQV Specialist (Contractor/Consultant)
to provide oversight of validation activities, ensuring compliance with cGMP, regulatory requirements, and SOPs.
This role supports commissioning, qualification, and validation (CQV) activities during facility start-up and transition to commercial operations.
Key Responsibilities
Provide QA oversight of validation/qualification activities for facilities, utilities, equipment, computerized systems, cleaning, processes, storage areas, CTUs, and shipping.
Review and approve validation documentation (URS, risk assessments, protocols, reports) to ensure compliance with SOPs and acceptance criteria.
Ensure deviations, investigations, and change controls during validation activities are properly managed with QA oversight.
Review SOPs related to qualification/validation activities.
Support audits, regulatory inspections, and ensure validation readiness.
Maintain compliance with EU/FDA cGMP, ISO, and industry standards (GAMP, ISPE, ASME, BPE).
Coordinate QA validation activities to meet project timelines.
Manage and support QA validation team performance, recruitment, and training.
Qualifications & Experience
B.Sc.
or B.Eng.
in Science or Engineering (e.g., Biochemistry, Chemistry, Engineering).
Experience in QA/Validation in biologics, pharma, or medical device manufacturing (FDA/EU regulated).
Strong knowledge of validation requirements in cGMP environments.
Familiar with root cause analysis tools (Ishikawa, FMEA, 5 Whys).
Strong planning, problem-solving, and critical thinking skills.
Ability to work independently in a fast-paced, cross-functional environment.
Niche Skills (Preferred/Recommended)
CQV Oversight
– commissioning & qualification for start-up facilities.
Validation Expertise
– facilities, utilities, equipment, cleaning, computerized systems.
Regulatory Knowledge
– EU GMP Annex 15, FDA 21 CFR Part 11, ISO, GAMP 5.
Quality Systems
– deviations, CAPA, change control, audit readiness.
Risk Management Tools
– FMEA, Ishikawa, fault tree analysis.
Technical Documentation
– URS, validation master plans, IQ/OQ/PQ protocols.