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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 lifesaving 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 lifechanging career.

Learn about the Danaher Business System which makes everything possible.

What youll 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 riskbased 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

• Bachelors 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 & rootcause 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.

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Join our winning team today. Together well accelerate the reallife impact of tomorrows 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.

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