Annex 1 Process Expert Drug Product (m/f/d)

Lonza

View: 155

Update day: 26-03-2024

Location: Visp Valais VS

Category: Pharmaceutical / Chemical / Biotech

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Switzerland, Visp

Randstad (Switzerland) AG is looking for an experienced Process Expert with a relevant backround in Drug Product to join the team in Visp, Switzerland. This role is temporary until the end of the year 2023.

Today, Lonza is a global leader in life sciences operating across three continents. While Lonza works in science, there’s no magic formula to how he does it. Their 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.

Key responsibilities:

  • Being accountable for identification and implementation of the new Annex 1 requirements related to regulations for sterile manufacturing and aseptic practices
  • Ensure that requirements and processes are aligned with best industry practices and trends
  • Collaborate closely with different sites producing sterile product and act as a link between different departments (Operations, QA, QC, global functions, etc.)
  • Responsible for performing gap analysis and risk assessment in collaboration with local and global SMEs for aseptic operations
  • Define and organize appropriate trainings on the identified implementation related to the new Annex 1 requirements
  • Actively define the communication strategies with the health authorities and our customers

Key requirements:

  • Bachelor’s/ master’s degree / PhD, preferred area of study: Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy or equivalent scientific degree
  • At least 2 years of experience in aseptic filling in the pharmaceutical or biotechnology industry
  • Preferred knowledge of sterile filtration, freeze drying, CCIT and single use systems
  • Proven experience and competence in Good Manufacturing Practice (cGMP) and familiar with new Annex 1 requirements
  • Fluent in English
  • Highly collaborative, results oriented and with excellent interpersonal communication skills

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.

Reference: R50155
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