(Senior) QA Expert Compliance, PQS and training 80-100%

vor 2 Wochen

Basel, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three 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.

This is a new and exciting role within the DPS QA Compliance team. The successful candidate will support the establishment and maintenance of the Pharmaceutical Quality Management Systems (PQS) in the sterile Drug Product Manufacturing facility in Stein.

Key responsibilities:

  • Ensures training at site level is harmonized with Global Training concept and meets all current regulatory expectations; performs QA oversight for training including the Learning Management System; ensures DPS employees are supported and trained according to the needs of their role
  • Owns, reviews and approves Changes, Deviations, CAPAs, Investigations
  • Document management – acts as author/ reviewer or approver of GxP documentation
  • Supports site Quality risk management activities
  • Contributes to the implementation of governing documents at site level
  • Performs trending activities, including KPI reporting and data handling
  • Contributes to the site inspection readiness; acts as SME during audits/ HA inspections for own QA Compliance topics
  • Supports the maintenance of the QMS in general
  • May support QMS activities for combination products
  • Support general QA Compliance activities as required

Key requirements:

  • BSc. or MSc. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences or related field
  • At least 5-10 years’ experience in Quality Assurance in pharmaceutical industries and CGMP controlled, preferably in Sterile Manufacturing
  • Fluency in English and German
  • Very good communication skills and cooperation skills
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive; solution-orientedenvironment or similar

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.

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