Website Asset Recruitment
QA Validation Specialist -Dundalk
A new and exciting contract opportunity now exist at our clients Advanced Technology Vaccines Manufacturing Facility at their Dundalk Site for a QA Validation Specialist
Reporting to the Head of CSQ/ENG QA, the QA Validation Specialist will be responsible and accountable for developing QA validation procedures and ensuring compliance to legislative and local practices for execution and documentation of all qualification/validation activities and QA related activities, e.g., document review and approval, to release facility, utility and equipment for GMP production and testing.
§ Responsible for preparing quality review and ensuring QA approval of all qualification/ validation documentation, including computer system validation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
§ 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. On-site monitoring of CQV activities
§ Review and gap closure of existing qualification documentation, as needed. Drive deviation management and provide oversight for qualification/ validation related deviations. Ensure corrective action / preventative action measures are implemented to drive improvement.
§ Develop, write, review and approve SOPs and controlled documents to support the site qualification/ validation activities and in accordance with applicable standards, regulations and client requirements.
§ Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.
§ 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 environmental health/safety practice, rules and regulations.
§ Actively participate in internal and external audits as SME for validation processes and documentation.
§ Experience in facility, utility, equipment, CSQ/ validation planning, execution and documentation.
§ Experience with GMP processes like GDP, change control, non-conformance management, corrective and preventative actions, and SOP writing.
§ Minimum 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 role
§ Previous experience leading or coordinating qualification/ validation teams, preferably green field environment.
§ Experience working in Quality Assurance role in a GMP Life Science environment.
§ Strong knowledge of GxP regulations (e.g. EU-GMP Guideline, Annex 11/15, SFDA)
§ Demonstrated understanding of principles of Qualification/ Validation, including strong knowledge of Facility/ Utility/ Equipment Qualification, Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.
§ Scientific or Engineering Degree or related discipline preferred.
§ This is a 6 month contract role and possible extensions for another 4 or 6 months with 2 weeks’ notice