LSC have an exciting contract opportunity for a Sr Quality Assurance Specialist to join a leading biotech company based in Dublin.
This is your chance to be part of groundbreaking projects and ensure the highest quality standards in pharmaceutical manufacturing. As a Sr Quality Assurance Specialist - Technical, you'll be at the forefront of biotechnology innovation, working on high-impact projects that make a real difference in patients' lives. The company offers a collaborative work environment, state-of-the-art facilities, and the opportunity to work with cutting-edge technologies. The Sr Quality Assurance Specialist role offers a unique blend of technical expertise and strategic thinking, perfect for those who thrive in a fast-paced, cutting-edge environment.
Primary responsibilities
- Lead QA oversight for operational readiness, validation, and technology transfer activities
- Review and approve critical validation documentation for integrated line qualifications and media fills
- Provide QA leadership in designing new rooms and developing contamination control strategies
- Serve as the QA Lead for technology transfer and new product introduction activities
- Manage quality risk assessments and ensure compliance with global validation standards
Qualifications and Skills
- Bachelor's or Master's degree in Science, Engineering, Biotechnology, or related field with minimum 8 years' experience in pharmaceutical or biotechnology manufacturing
- Proven expertise in facility startup and Quality Oversight of Operational Readiness
- In-depth knowledge of EU/FDA GMP, Annex 1, and process validation lifecycle requirements
- Experience in aseptic operations, particularly vial and syringe filling
- Strong technical understanding of aseptic manufacturing and validation
- Excellent collaboration, communication, and decision-making skills
If you're passionate about quality assurance in biotechnology and ready to take on the challenge of a Sr Quality Assurance Specialist Technical role, we want to hear from you!
Apply now by sending your CV and a brief cover letter outlining your relevant experience or contact Kathy Gillen on 021 4718212 for more details.
Please note all applicants must have a valid work permit for at least 12 months. LSC do not offer work permit or visa sponsorship.
