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Validation manager

Sligo
Morgan Mckinley
Validation manager
Posted: 12 June
Offer description

Job Opportunity: Validation Manager - Sligo Industry: Biologics / Pharmaceutical Employment Type: Full-Time Our client, a leading biopharmaceutical organization, is currently seeking an experienced Validation Manager to join their state-of-the-art facility in Sligo. This is a fantastic opportunity to play a pivotal role in leading and developing a site-wide validation program in a fast-paced, regulated environment. Key Responsibilities: Lead a team of validation professionals, providing guidance and oversight for all validation activities on site. Manage the qualification and validation of equipment, utilities, processes, and software, ensuring alignment with internal policies and external regulatory standards (FDA, EMA, cGMP, GAMP). Develop and maintain comprehensive validation project plans, protocols, and reports, ensuring full compliance with cGMP. Review, approve, and oversee execution of validation and qualification documentation and manage associated deviations and change controls. Provide Quality Assurance support for validation-related investigations, including implementation of corrective and preventive actions. Ensure accurate documentation of all validation work in accordance with regulatory expectations. Support onboarding and training of new team members and engage in cross-training initiatives. Drive continuous improvement efforts across manufacturing, quality, safety, and training systems. Collaborate across departments to enhance operational effectiveness and support strategic business goals. Represent the validation function in cross-functional and cost-improvement initiatives. Requirements: A qualification or degree in Engineering, Science, or a related discipline. Minimum 3 years' validation or quality experience in a cGMP regulated, sterile/aseptic environment, with specific exposure to commissioning and qualification. At least 2 years of team leadership or people management experience. Proven knowledge of current Good Manufacturing Practices and regulatory expectations in the pharmaceutical industry. Strong communication, presentation, and analytical skills. Demonstrated ability to lead teams, manage priorities, and work both independently and collaboratively. Skills: Validation Biopharma Quality

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