Overview
Are you looking for a new challenge within the pharmaceutical industry? This role assisting with the launch of two pharmaceutical products is perfect for you. This is an exciting time to join a rapidly growing pharmaceutical company preparing for the commercial launch of two products by the end of the year. With significant investment in infrastructure and talent, the company is scaling operations and building a high-performing quality team to support its transition into commercial manufacturing. This role offers strong career development potential in a dynamic and fast-paced environment.
Hobson Prior is seeking a QA Validation Specialist to support the qualification and validation of equipment, computerised systems, facilities, and utilities in a regulated pharmaceutical environment. This role is critical in ensuring compliance with GMP standards and maintaining a validated state across site operations. The successful candidate will work cross-functionally with engineering, production, and quality teams to support ongoing and project-based validation activities.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities
Review and approve qualification and validation documentation (IQ/OQ/PQ) for equipment, systems, facilities, and utilities.
Provide QA oversight during execution of qualification, requalification, and validation activities.
Develop and maintain the Site Validation Master Plan (SVMP) in alignment with regulatory expectations and internal policies.
Generate and execute project-specific validation plans and validation master plans.
Coordinate with manufacturing and engineering teams to ensure timely and compliant completion of validation tasks.
Lead or support investigations into deviations or deficiencies related to qualification activities, and drive corrective and preventive actions (CAPAs).
Prepare and review SOPs, protocols, reports, and technical drawings related to validation.
Review and approve calibration and preventive maintenance schedules and associated work orders.
Conduct and support risk assessments, technical studies, and investigations impacting the validated state.
Participate in audits and inspections, providing subject matter expertise on validation-related topics.
Qualifications & Experience
Degree in a scientific discipline (e.g., Chemistry, Biology, Engineering).
Proven working years in a GMP-regulated pharmaceutical or biopharmaceutical environment.
Strong working knowledge of validation lifecycle principles, including IQ/OQ/PQ.
Experience with Site Validation Master Plan development and maintenance.
Familiarity with HPRA and FDA regulatory requirements.
Excellent documentation, communication, and cross-functional collaboration skills.
For more information, please contact Billy O'Brien.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - privacy policy.
