Are you interested in taking the next step in your career with a global leader in pharmaceuticals and healthcare? Are you ready to challenge yourself? Are you an experienced QA Validation Engineer with background working in qualification of benchtop equipment and systems? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!
Job Description
Our client is looking for a QA Validation consultant to join their team in Dundalk. Based within the QA department, the role will be responsible for providing quality oversight for engineering and validation related activities, ensuring the timely review and approval of documentation and resolution of any internal or external quality issues in accordance with Site procedures.
Key Responsibilities
Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications, and other applicable acceptance criteria.
Review and approve validation lifecycle documentation, including URS, specification documents, Test Protocols/Reports, risk assessments, data integrity risk assessments, and traceability matrices.
Participate in event/deviation investigations and change evaluations relating to engineering, validation, and computerized systems.
Participate in software, equipment, and instrument qualification where necessary.
Provide quality oversight of processes and procedures related to DI, Computerised Systems & Automation compliance.
Provide quality support for Electronic Data Review and Data Management.
Support a safe working environment by complying with all pertinent environmental health/safety practice, rules, and regulations.
Assist in the implementation of global standards and procedures into the site Quality Systems.
Participate in other projects/duties as assigned.
Flexibility to take on additional tasks and responsibilities at the discretion of the QAV Lead.
Key Requirements
Thorough knowledge of GxP regulations (e.g., EU-GMP, FDA, ISO, GAMP).
Academic degree in Computer Systems, Engineering, or Natural/Applied Sciences (e.g., Chemistry, Pharmacy, Biology, Biotechnology, Engineering, IT).
Robust experience (≥5 years) in a Quality Engineering/Validation role for biologics, medical devices, or pharmaceutical manufacturing.
Demonstrated experience in change control and deviation management.
Demonstrated experience in equipment/facility/utility qualification and computerised system validation.
Solid understanding of principles of New Product Introduction, Shipping Validation, Cleaning Validation, and Process Validation.
Ability to operate across functional boundaries, both internal and external.
Independent, self‑motivated, organized, able to multi‑task in project environments and skilled in communication and collaboration.
Prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making.
Minimum of 5 years recent experience in QA Validation focused roles, including:
Qualification of low‑medium complexity analytical equipment (benchtop).
Experience with clean utilities/clean rooms is not a priority, even though it is listed in the spec.
QA compliance experience, less focus on execution tasks.
Willingness/ability to be full‑time on site.
Clear communicator.
Benefits
Competitive and attractive employee compensation package.
Pension contributions.
Health insurance.
Paid holidays.
Location: Dundalk, Ireland | on‑site
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