Quality Assurance Senior Specialist (Contract – Dundalk, On-site)
Pay Rate:
€29.44/hr – €52.05/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.