Manager Customer Audits

Vor 6 Tagen

Visp, Schweiz Lonza Vollzeit

Switzerland, VispToday Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

For our site in Visp we are looking for a Audit Manager Quality Assurance with a strong scientific background and experience in GMP manufacturing. He/She is responsible for the planning, execution and documentation of all **customer audits** and for the management of **internal audits** (self-inspections) and paper inspections by regulatory authorities. The audit Manager also supports the QA Management in the preparation, execution and documentation of on-site **regulatory inspections**. The Audit Manager has face-to-face contact with Lonza’s customers on a regular basis and is therefore a key person for Lonza’s business.

**Key responsibilities**:

- Planning, executing and documenting customer audits on the Visp site
- Responding to customer requests for audit dates
- Planning audits together with Lonza project teams, based on the customers’ agendas
- Accompanying the customer throughout the audit (plant tours, documentation review etc.)
- Presenting Lonza’s Quality systems to the customer
- Documenting the customer audits in TrackWise
- Coordinating the responses to audit observations with the project team and ensuring that the customer receives the responses within the given timelines
- Providing KPI data to QA Management on a regular basis
- Conducting internal audits (self-inspections)
- Scheduling, preparing and performing internal audits as per approved audit schedule
- Agree on an appropriate CAPAs and monitor the implementation to a satisfactory conclusion
- Supporting QA management during regulatory inspections
- Organizing of preparation meetings and SME trainings
- Support in Front Office/Back Office as required
- Responsible for QA aspects of paper inspections
- Coordinating with Regulator Affairs to provide all required documents
- Answering queries from regulatory authorities with respect to paper inspections

**Key requirements**:

- PhD or Master’s degree in chemistry, biotechnology, life sciences
- Excellent communication skills in English and German (fluency in both languages is required)
- Professional appearance and attitude to establish and maintain excellent working relationship with customers
- Excellent verbal, written and interpersonal communications skills
- Excellent organizational skills
- Ability to work in partnership as an active member of a team and/or cross functional working groups
- Ability to prioritize and manage work to meet timelines in a fast-paced environment
- General knowledge of manufacturing processes and analytical methods
- Competent level of general IT skill is required
- Experience in auditing chemical/biopharmaceutical processes is an asset

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: R59285
- Apply

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