On behalf of our client, we are currently recruiting for a QA Validation Manager for a 12 month maternity contract cover.
The purpose of this role is to manage the qualification and validation of equipment, control systems, and computer systems for the Life Sciencies business in Ireland. The role holder must demonstrate experience working within a Quality Management System aligned with cGDP/cGMP requirements, along with the ability to successfully deliver and facilitate quality-related project work.
Experience in validation and qualification activities, including thermometric studies relevant to facilities and systems, is preferred. The Quality Validation Manager should also have a strong understanding of the pharmaceutical industry and its supply chain processes.
Bachelor’s degree (Level 7 or Level 8) in Science, Engineering, Pharmacy, Quality, or a related discipline. Formal training or certification in Validation, Quality Assurance, or GxP compliance (e.g. CSV, GMP/GDP, Annex 11/15) is highly desirable.
Demonstrated experience working within EU GMP/GDP regulatory frameworks in the pharmaceutical, medical devices, or life sciences industry may be considered in lieu of formal qualifications.
Strong understanding of equipment qualification (IQ/OQ/PQ) and computer system validation (GAMP 5).
Proven experience managing validation and quality systems in a GxP-regulated environment.
Excellent written and verbal communication skills, particularly for audits and regulatory interactions.
Responsibilities
Provide management support across above topics/functions.
The purpose of this role is to manage the qualification and validation of equipment, control systems, and computer systems for the Life Sciences business in Ireland. The role holder must demonstrate experience working within a Quality Management System aligned with cGDP/cGMP requirements, along with the ability to successfully deliver and facilitate quality-related project work.
Experience in validation and qualification activities, including thermometric studies relevant to facilities and systems, is preferred. The Quality Validation Manager should also have a strong understanding of the pharmaceutical industry and its supply chain processes.
Manage the qualification and requalification schedule for all GxP-critical equipment and systems used across the business.
Act as a key point of contact for clients’ day-to-day Quality Assurance enquiries.
Assess service suppliers for GxP criticality.
Be responsible for supplier qualification, including approval, ongoing assessment, and requalification of GxP-critical suppliers.
Monitor and review temperature and humidity performance of key equipment on a daily basis, reporting issues to the RP and clients.
Support new business initiatives within Quality Assurance, with particular focus on qualification and validation activities.
Approve all GxP systems and equipment on behalf of Quality Assurance and present to the RP/QP for final approval.
Liase with the planning departments in relation to resources availability
Requirements for the Job
Manage the Computer System Validation process on behalf of the Quality Assurance team, ensuring compliance with GAMP 5 requirements and supporting team accountabilities.
Provide leadership to other colleagues in relation to the organisation of achieving site and company objectives.
Ability to create requirements documents, SOPs etc..
Identify potential - nurture development and create a leadership succession path.
Excellent interpersonal, leadership, motivational and planning skills
Proficient in Microsoft Office and relevant quality and warehouse management systems.
Maintain awareness of qualification and validation regulations and guidelines, completing gap analyses to ensure ongoing compliance.
Complete qualification activities with mapping contractors, ensuring all documentation is maintained in line with GxP requirements.
Support supplier and equipment selection, approval, and implementation in collaboration with key stakeholders.
Ensure compliance with HPRA and Department of Health requirements, with the aim of eliminating non-compliance findings during regulatory inspections.
Assess all equipment and systems used within the business to determine GxP criticality.
Maintain Standard Operating Procedures for qualification, validation, re-qualification, and re-validation activities.
Undertake Quality Assurance activities relating to computer system validation and equipment qualification.
Be accountable for temperature monitoring across all areas of the facility.
Maintain up-to-date knowledge of relevant EU and Irish regulatory requirements.
Manage and deliver GDP and GMP training to colleagues across the business.
Work collaboratively with operational and functional teams across sites to maximise efficiencies and best practice.
Act as an advisor to the business on Quality Assurance and regulatory requirements for Life Sciences.
Support the management of deviations, including root cause investigations and corrective actions.
Participate in and support regulatory inspections and audits to ensure compliance with GxP standards.
Qualifications & skills
Bachelor’s degree (Level 7 or Level 8) in Science, Engineering, Pharmacy, Quality, or a related discipline.
Formal training or certification in Validation, Quality Assurance, or GxP compliance (e.g. CSV, GMP/GDP, Annex 11/15) is highly desirable.
Demonstrated experience working within EU GMP/GDP regulatory frameworks in the pharmaceutical, medical devices, or life sciences industry may be considered in lieu of formal qualifications.
Strong understanding of equipment qualification (IQ/OQ/PQ) and computer system validation (GAMP 5).
Proven experience managing validation and quality systems in a GxP-regulated environment.
Excellent written and verbal communication skills, particularly for audits and regulatory interactions
Strong knowledge of warehouse operations and associated quality and regulatory compliance requirements.
Demonstrated knowledge of equipment qualification activities, including IQ, OQ, and PQ.
Good understanding of EU GMP Annex 11 and Annex 15.
Fully conversant with EU and Irish GMP/GDP regulations and ISO 9001 requirements.
Previous experience in a QA Validation Manager or equivalent role within the Pharmaceutical or Medical Devices industry.
Life Science logistics industry experience
Experience in hosting regulatory authority and client audits.
Strong problem-solving skills, with the ability to anticipate and resolve issues, assess data discrepancies, and understand root causes and potential impacts.
Strong computer skills, including experience with Warehouse Management Systems (WMS).
Proven track record in Quality Assurance, including auditing, within GMP/GDP/GCP/GxP environments.
Experience in reviewing and approving Quality Agreements, Technical Agreements, and SLAs.
Experience in the management of Quality Systems in compliance with GxP requirements.
Excellent organisational and time-management skills.
Salary approx €60k Per Annum
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail ldunne@thornshaw.com
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