Validation Officer - 12 Month Contract

Basic Role Summary:

A key role within the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Officer is responsible for the review and issuance of validation protocols and reports. The role also supports the coordination and execution of validation activities, including process, cleaning, equipment, and computer system validation, across relevant departments within the Chanelle Group.

Location: Onsite at our facility in Loughrea.

As our Validation Officer, your key responsibilities will be as follows:

• Contribute to the preparation and review of the Validation Master Plan for process and cleaning validation.

• Manage validation requirements across Chanelle and third-party suppliers/CMOs.

• Prepare, review, and issue validation protocols and reports for equipment, cleaning, process, and computer system validation.

• Maintain and take ownership of the cleaning validation strategy at Chanelle.

• Manage the cleaning validation master plan in compliance with EU regulatory expectations.

• Support implementation of process validation for new products in line with regulatory submissions and registered specifications.

• Coordinate validation execution with Production, Quality Control, and R&D teams.

• Establish, implement, and manage validation and revalidation activities.

• Liaise with contract manufacturing customers to obtain approval for protocols and reports where required.

• Review and manage change controls and non-conformances for validation impact.

• Update quality documentation relating to validation activities.

• Identify training requirements related to validation processes.

• Ensure timely completion and closure of validation protocols.

• Conduct internal audits as required.

• Perform risk assessments and investigation reports relevant to validation activities.

• Maintain the validation documentation system.

• Lead cross-functional teams in resolving technical validation issues.

• Support preparation for and participation in regulatory and customer audits.

Qualifications and Experience:

• Minimum Bachelor of Science or Engineering degree.

• Experience in validation within a GMP-regulated pharmaceutical environment desirable.

• Knowledge of process and cleaning validation requirements.

• Experience supporting audits and regulatory compliance activities desirable.

Skills and Competencies:

• Strong written and verbal communication skills.

• Ability to work independently in an analytical and regulated environment.

• Good computer skills, including Word, Excel, and statistical tools.

• Understanding of validation principles and regulatory expectations.

• Ability to conduct internal audits and support external audits effectively.

Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.