QA CSV / QMS Specialist

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

What you’ll do

• Provide CSV support in key global projects concerning computerised system, ensuring compliance with the QMS and regulations.

• Review and approve GxP assessment as well as Validation Master Plans, and where necessary the entire Validation Life Cycle documentation. Supports projects and ongoing maintenance of the systems.

• Supports the GxP systems and application projects as a QA CSV representative, by reviewing, approving and authorising the change controls where applicable.   

• Working closely with the Biopharma QARA CSV IT and IT Compliance Manager supports the roll out of the CSV training and education.

• Provides input, reviews and approves of quality records related to CSV including Deviation, Change Controls and CAPAs.

• Supports the Biopharma CSV team in implementation of the risk-based approach to CSV system, in line with the regulation and ensuring QMS compliance.

• Supports Document and Training management from a global QMS perspective.

 Who you are

• Bachelor's Degree and 5+ years working in regulated medical devices, pharmaceutical or life sciences industry in Quality or related functional roles specific to Computerized System Validation.

• Quality Assurance/ Quality Engineering experience in CSV in a GMP environment is essential, proficiency on GAMP 5 and FDA or EU regulations.

• Understanding Medical Devices QMS and regulatory requirements including but not limited to FDA CFR 21 820 (advantage), and ISO 13485 and ISO 9001

• Exceptional analytical, problem solving & root-cause analysis skills.

• Excellent organizational, presentation, meeting facilitation and report writing skills.

• Excellent written and verbal communication skills. Experienced in working globally. Prior experience in IT system Validation will be advantage.

• Demonstrated good collaboration skills and expertise to effectively communicate the organization.

• Able to prioritise own activities to ensure critical deadlines met.

#LI-onsite

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.