Job Title: Quality Assurance Senior Specialist – CSV / CQV (Contract)
Location: Dundalk, Co. Louth
Work Mode: Fully Onsite (No Hybrid / Remote)
Role Overview
An excellent contract opportunity has arisen for a Quality Assurance Senior Specialist (CSV/CQV) to support a manufacturing facility during a critical start-up and transition phase. The role reports to the QA CSQ/CQV Lead and is responsible for providing QA oversight of all validation and qualification activities, ensuring full compliance with cGMP, regulatory requirements, and internal SOPs.
This role plays a key part in supporting Commissioning, Qualification, and Validation (CQV) activities and ensuring a smooth transition from project execution to routine commercial operations.
Key Responsibilities:
Provide QA oversight for qualification and validation of:
* Facilities, utilities, and equipment
* Computerized systems (CSV)
* Cleaning and manufacturing processes
* Storage areas, CTUs, and shipping processes
* Review and approve validation documentation including:
* Validation plans, URS, risk assessments, protocols, and reports
* Ensure QA oversight of deviations, investigations, and change controls arising during validation activities
* Review and approve SOPs related to qualification and validation
* Support regulatory inspections and client audits
* Maintain validation status of the facility in line with cGMP requirements
* Coordinate QA validation activities to ensure schedule adherence and timely delivery
* Provide subject matter expertise across CSV and CQV activities
* Support and guide validation teams as required
Education & Experience Requirements:
* Bachelor's degree (BSc or BEng) in a Scientific or Engineering discipline
Proven experience in QA, Quality Engineering, or Validation roles within:
* Pharmaceutical, biologics, or medical device manufacturing
* FDA / EU regulated environments
* Strong understanding of cGMP manufacturing facility validation requirements
* Hands-on experience with computer system validation (CSV)
Technical Knowledge & Expertise
* Strong knowledge of GxP regulations (EU GMP, FDA, ISO)
* Familiarity with industry standards including:
* GAMP 5, ISPE, ISO, ASME, BPE
Experience with:
* Root cause analysis tools (FMEA, Ishikawa, etc.)
* Risk-based validation approaches
Key Skills:
* Independent and self-motivated
* Strong planning, organisational, and time management skills
* Ability to work in fast-paced, project-driven environments
* Excellent critical thinking and problem-solving skills
* Ability to work cross-functionally with internal and external stakeholders