Senior QA Specialist, Process Validation 80-100

vor 12 Stunden

Visp Valais, Schweiz Lonza Vollzeit

Switzerland, Visp

Location:
Visp, Hybrid Work Model. Relocation assistance is available for eligible candidates and their families, if needed.

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

We are currently looking for a Senior QA Specialist (f/m/d) Process Validation for the expansion of our team here at our site in Visp . In this role, you will be QA responsible for manufacturing process validation in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs).

What You'll Get

  • An agile career and dynamic working culture
  • An inclusive and ethical workplace
  • Compensation programs that recognize high performance
  • A variety of benefits dependant on role and location

The full list of our global benefits can be also found on .

What You'll Do

  • Ensure the manufacturing processes: APIs and Intermediates are in a validated state during their whole lifetime according to Lonza procedures, and in compliance with regulatory guidance
  • Preparation of comprehensive process specific Validation Master Plans, describing the individual studies required for process validation
  • Leading the process validation teams including communication with customers
  • Support R&D teams during the process design phase
  • Preparation of the validation protocols and reports for the studies performed at manufacturing scale
  • Assessment of changes and deviations during manufacturing for their impact on validation
  • Preparation and maintenance of a documented continued process verification plan

What We're Looking For

  • Master degree or PhD in Chemistry/ Biotechnology or any related field
  • Significant experience in the area of biopharmaceutical manufacturing, preferably in a validation function as well as strong background in cGMP
  • Broad knowledge of manufacturing processes in GMP environment
  • Experience in interacting with all kind of interfaces within the organization as well as with regulatory agencies (Swissmedic, FDA etc.)
  • Fluency in English language required, good German language skills would be an advantage
  • Managing internal and external customer relations professionally and effectively

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R71026

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