The Osborne Tech and Eng team is very pleased to be working with our client, a global leader in the manufacturing of medicated feed additives, advanced nutrition solutions, vaccines, and specialty chemicals for a diverse range of industrial markets. They are committed to the highest standards of quality and compliance to deliver safe, effective products worldwide.
Position Summary:
The QA Specialist (Validation) will play a critical role within the Quality Assurance team, based at the company’s Sligo site. This individual will be responsible for overseeing and ensuring the validation of processes, equipment, and utilities to meet GMP and regulatory standards. The role involves reviewing and approving validation documentation and supporting the qualification of facilities and equipment to ensure they are fit for ongoing manufacturing operations. The QA Validation Specialist will collaborate closely with various departments, including Quality Control, Manufacturing, Engineering, and Technical Services, to support quality assurance and validation activities.
Key Responsibilities:
Serve as a primary Quality Assurance contact for technical expertise, guidance, and feedback on compliance issues, including validation strategies, new product introductions, and manufacturing processes.
Review, approve, and oversee validation documentation related to the qualification of facilities, equipment, and utilities to support both startup and ongoing manufacturing operations.
Manage areas within the Quality Management System (QMS) to ensure product manufacturing is in compliance with GMP and regulatory requirements. Key areas include:
Deviation investigations
Change Control and CAPA management systems
Internal/External auditsVendor Management
Manufacturing Batch
Record reviews
Production material assessments
Generate, review, and approve SOPs and other relevant documentation to ensure compliance with GMP and regulatory standards.
Ensure that schedules for reviewing and approving GMP/validation documents are aligned with technology transfer timelines and new product introduction projects.
Lead QA activities in cross-functional project teams, collaborating with Operations, Quality Control, Engineering, and other departments.
Actively contribute to continuous improvement initiatives within the organization.
Perform other duties as assigned to support business needs.
Qualifications & Experience:
A third-level qualification in a relevant science or engineering discipline.
A minimum of 5 years of experience working in a GMP-compliant Quality Assurance environment, with a strong focus on validation and qualification activities.
Experience in the Validation function, with in-depth knowledge of the project life cycle and cGMP regulations.
Core Competencies:
Strong understanding of GMP compliance and industry quality standards.
Comprehensive knowledge of Quality Management System (QMS) procedures and technical documentation.
Exceptional analytical, problem-solving, and decision-making skills.
Meticulous attention to detail with significant experience in document review and approval.
Excellent technical writing skills, including the preparation of deviation reports and SOPs.
Ability to drive tasks to completion, demonstrate troubleshooting skills, and maintain a high standard of quality.
What’s in it for you?
This is an exciting opportunity to be part of a global leader in the manufacturing industry, offering a dynamic and challenging role within a collaborative and forward-thinking team. The QA Validation Specialist will be instrumental in driving product quality and regulatory compliance across manufacturing operations.
To be considered for this position apply today or call Paula Ferrie on 071 930 0020. If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search. Osborne are proud to be an Equal Opportunity Employer If you are interested in finding out more about the above role and would like to be considered for this or other suitable roles that we may have available for your skill set – please attach your CV via the link provided. Please submit your updated CV in Word Format.
