QA Operations Manager DPS (Drug Product Service) (f/m/d)

☞ Lonza

View: 140

Update day: 03-04-2024

Location: Visp Valais VS

Category: Pharmaceutical / Chemical / Biotech Consulting / Customer Service

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Switzerland, Visp

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.

You will represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.

Key responsibilities:

  • Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations

  • Ensure shop floor QA oversight

  • Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs

  • Review and approve GMP-relevant documents and SOPs (e.g. batch records, product specific documentation)

  • Responsible to present Drug Product QA topics during the conduction of all customer audits / regulatory inspections / internal audits within DPS Visp / Biologics / Visp site

  • Provide GXP-related trainings to Module D Operations personnel (e.g. GMP, Good Documentation Practice)

  • Support project / product specific risk assessments or regulatory specific risk or gap assessments

  • Support continuous improvement programs to establish an effective Quality Management System for DPS Visp

Key requirements:

  • Master of Science or equivalent in chemistry, biology, biotechnology or a related field

  • Long term experience working in the GMP environment of the pharmaceutical industry

  • Experience working in a QA department would be an advantage

  • English language skills are required, German language is an advantage

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: R50764
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Deadline: 18-05-2024

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