Are you a QA Validation Specialist with 3+ years experience working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function?
This is a contract role based in Louth.
Job Description Our 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.
Key Responsibilities:
Prepare quality reviews and ensure 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 in accordance with client policies.
Ensure all equipment and processes are safe, effective, and qualified in compliance with industry standards and regulatory expectations.
Provide 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.
Provide clear expectations regarding validation standards and report monthly validation KPIs and metrics, ensuring opportunities for improvement are identified and actioned accordingly.
Participate in the New Product Introduction (NPI) and technology transfer process, ensuring all associated protocols are conducted and in place in line with project timelines and impact assessments.
Support team members for more complex processes and decisions.
Ensure compliance with regulatory and local protocols.
Lead by example and ensure associated risk assessments are conducted in line with site expectations, providing a safe working environment by complying with all pertinent environmental health/safety practices, rules, and regulations.
Liaise actively with other functional areas to provide support and ensure standards are met.
Ensure corrective action/preventative action measures are put in place to drive improvement.
Participate in 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 SOPs.
Participate in other projects/duties as assigned.
Requirements Minimum of 3 years' experience working in a Biologics or similar GMP environment as part of an engineering, technical services, or operations function.
Previous experience leading an established validation team; experience in a green field environment is advantageous.
Experience working in a Quality Assurance role in a GMP Life Science environment.
Demonstrated understanding of principles of Validation and New Product Introduction along with 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.
Strong organisational, communication, coordination, and meeting facilitation skills.
Excellent interpersonal, verbal, and written communication skills.
Good critical thinking skills and troubleshooting abilities to drive improvement and build opportunities.
Self-starter and self-motivated; organized with good attention to detail.
Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
Results oriented, with the ability to manage multiple priorities in a short period of time.
Collaborative and inclusive approach to work and colleagues.
Must be willing to travel internationally as required to fulfil the responsibilities of the position.
Package Contact Karen McHugh is the consultant managing this position.
If you are a Validation Engineer interested in roles based in Louth, you can contact Karen by e-mail at
or phone for a confidential chat.
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