QA Validation Specialist

QA Resources Ltd; Cork; On-site; EUR 40,000 - 60,000; Full time

Job summary

A leading QA consultancy is seeking a QA Validation Specialist for a contract role in Cork. This position involves reviewing and approving validation documentation, ensuring compliance with regulatory requirements, and providing QA support for equipment qualifications. The ideal candidate must have a Bachelor's degree in a scientific or engineering discipline, at least 2 years of experience in the pharmaceutical industry, and strong knowledge of cGMP. Interested candidates should submit an updated CV.

Qualifications

• Minimum of 2+ years’ experience in the pharmaceutical industry.
• Experience in writing and approving cGMP documentation.
• Knowledge of Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation.

Responsibilities

• Review IQ/OQ/PQ protocols for software, equipment, and facilities.
• Develop validation protocols to ensure compliance.
• Assist in managing the site Validation Master Plan.
• Provide QA support for equipment qualification.
• Review vendor supplied documentation and author cGMP compliance documents.

Skills

QA Validation activities

cGMP knowledge

Strong interpersonal skills

Excellent organizational skills

Good verbal and written communication

Education

Bachelor’s Degree in scientific or engineering discipline

Job description

QA Resources are looking for a number of contract QA Validation Specialists for an exciting project based in Cork.

Role and requirements:

• Review of IQ/OQ/PQ protocols and reports for software, equipment and facilities and report on executed protocols, as required.
• Develop validation protocols and reports to ensure compliance with regulatory requirements.
• Assist in the management of the site Validation Master Plan and its timely execution.
• Act as a site contact for vendors where required, including off‑site meetings where applicable (e.g., F.A.T)
• Provide QA support for equipment qualification. Review and approve protocols and reports.
• Review and contribute to the development of User Requirement Specifications.
• Provide a review and approval of all vendor supplied documentation.
• Author documents that ensure cGMP compliance, such as investigations, CAPAs, reports and forms.
• Perform other related duties or projects as assigned.

Experience:

• Bachelor’s Degree required in a scientific or engineering discipline.
• Minimum of 2+ years’ experience in the pharmaceutical industry with excellent working knowledge of cGMP
• Experienced in QA Validation activities
• Extensive experience on writing and approving cGMP documentation
• Good communicator both verbally and written with strong interpersonal and excellent organizational skills.
• Software, Process, Cleaning, Equipment, Facilities, and Utilities Validation knowledge and /or experience is preferable.

Interested candidates should submit an updated CV to [e-mail]