Lead QA Specialist
Lead QA Specialist
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Salary Not Disclosed
1 Vacancy
Job Description
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. With associates across 40 countries Cytiva is a place where every day is a learning opportunity so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher we bring together dedicated technical expertise and talent to develop the next generation of lifechanging therapeutics.
Responsible for providing quality assurance leadership and support to the Process Design & Validation Services (PDVS) business unit. The PDVS team provides laboratory services to our BioPharma customers as well as supporting internal R&D and manufacturing projects.
This is an onsite position located at the Harbourgate site in Portsmouth UK.
What youll do:
- Take responsibility for BU QMS documentation and processes to ensure compliance with the Corporate ISO9001 QMS industry and regulatory requirements.
- Manage deviation and CAPA process. Ensure deviations are correctly captured investigated and trended and that appropriate CAPA activities are initiated and completed within agreed timelines. Monitor effectiveness of CAPA.
- Host customer third party and internal audits.
- Support the business in delivering against Quality KPIs.
- Support the Global PDVS Quality Leader on global Quality related initiatives.
Who you are:
- Bachelors degree in an applicable Science discipline or equivalent experience in a regulated manufacturing industry (e.g Pharma Biopharm Life Science Biotech).
- A minimum of 5 years working in Quality Assurance within Life Science or Biopharma manufacturing or laboratory environments.
- Handson experience with the requirements of applicable international quality systems (eg ISO9001 GMP).
- Excellent analytical problem solving & rootcause analysis skills.
- Experience in hosting or supporting customer regulatory or thirdparty audits.
It would be a plus if you also possess previous experience in:
- Continuous improvement methodologies & tools.
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.
For more information visit www.danaher.
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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
