Job DescriptionOur client is a leading international biotech company with a state of the art manufacturing facility in Louth.
Reporting to the Associate director of QA validation the Sr. QA Validation Specialist –will be responsible and accountable for developing the QA validation procedures and ensuring compliance to legislative and local practices for the review and approval of all qualification/validation documentation and QA related activities to the release of facility, utility and equipment for GMP production.Responsible for preparing the quality review and ensuring all approvals of qualification/validation documentation, including computer system validation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.Develop, write, review and approve SOPs and controlled documents to support site validation activities and in accordance with client policies.Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.Oversight for key functional areas (i.e.
PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations.Providing clear expectations regarding validation standards.
Report monthly validation KPIs andmetrics and ensure opportunities for improvement are identified and actioned accordingly.Actively participate in the New Product Introduction (NPI) and technology transfer process and ensure all associated protocols are conducted and in place in line with project timelines and impact assessments.
Provide support to team members for more complex processes and decisions.
In addition, ensure compliance to regulatory, and local protocols.Lead by example and ensure associated risk assessments are conducted in line with site expectations and provide a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.Liaise actively with other functional areas and provide support to ensure standards are met.
Ensure corrective action / preventative action measures are put in place to drive improvement.Actively participant the internal and external audits regarding validation processes and protocols.Represent the organisation in more complex risk and impact assessments.Perform all activities in compliance with client safety standards and SOPsParticipate in other projects/duties as assigned.Experience in change control, non-conformance, corrective and preventative actions, and validation practices.RequirementsMinimum of 3 years' experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function or other combination of experience and educational background that may otherwise satisfy the requirements of the rolePrevious experience leading an established validation team, working in a green field environment advantageous.Experience working in Quality Assurance role in a GMP Life Science environment.Demonstrated understanding of principles of Validation and New Product Introduction and strong knowledge of Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.Strong knowledge of GxP regulations (e.g.
EU-GMP Guideline, Annex 11/15, SFDA)B.Sc or B.Eng in a Scientific or Engineering related discipline preferred.Behavioural CompetencieStrong organisational, communication, coordination, and meeting facilitation skillsExcellent interpersonal, verbal, and written communication skillsGood critical thinking skills and troubleshooting to drive improvement and build opportunities.Self-starter and self-motivated; organized with good attention to detailComfortable working in a fast-paced environment and able to adjust workloads based on changing prioritiesResults oriented, with the ability to manage multiple priorities in a short period of time.Collaborative and inclusive approach to work and your colleagues.Engage cross functionally in conjunction with a site-based team.Must be willing to travel as required internationally to fulfil the responsibilities of the position.PackageHourly Contract Rate €50 - €65 per hour
