Quality Assurance Specialist - Compliance and Regulatory Expert
Life Science Consultants is seeking a highly motivated and experienced Quality Assurance (QA) specialist to join our team in Dublin. This exciting opportunity offers a seasoned professional the chance to take on new challenges and contribute to the success of clients.
Key Responsibilities:
* Review and approve quality agreements ensuring compliance with regulatory requirements.
* Release incoming materials for use in manufacturing operations, guaranteeing timely delivery and adherence to quality standards.
* Support qualification of new suppliers/materials, maintaining high-quality control throughout the process.
* Assess supplier change notifications for impact on qualification status, ensuring ongoing compliance.
* Support material certification and direct dispense programs, promoting efficient processes.
* Author, review, and approve QA-related procedures, ensuring accuracy and relevance.
* Support Operational Excellence programs and champion continuous quality improvement initiatives, driving excellence and innovation within the organization.
* Perform QA review, assessment, and approval activities for Biologics Manufacture, including Change controls, Deviations/Investigations, CAPAs, and other associated documentation.
Qualifications & Experience:
* BSc in Science or related discipline with a minimum of 2 years' Supplier Quality or related experience in a Biologics or Pharmaceutical environment.
* A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing.
* Detailed knowledge of Biologics Processing would be advantageous.
* Ability to work independently while also being part of a team, demonstrating excellent collaboration skills.
* Excellent communication, presentation, time-management, and organizational skills are essential for this role.
* Employees are expected to display desired behaviours enabling them to be successful and perform at their highest level.
This role requires applicants to have a Stamp 1 G or a Stamp 4 visa, as they will be working in Ireland. Please note that Life Science Consultants cannot provide visa sponsorship.