For our site in Visp, Switzerland, we are seeking a Senior QA Specialist / Customer Audit Manager (f/m/d) with a strong scientific background and experience in GMP manufacturing. Relocation assistance is available for eligible candidates and their families, if needed. This role is responsible for the planning, execution and documentation of all customer audits, management of internal audits (self-inspections), and paper inspections by regulatory authorities. The Audit Manager also supports QA Management in the preparation, execution and documentation of on-site regulatory inspections and has regular face-to-face contact with Lonza’s customers.
Tasks
- 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 customers’ agendas
- Accompanying customers throughout the audit (plant tours, documentation review, etc.)
- Presenting Lonza’s Quality systems to customers
- Documenting customer audits in TrackWise
- Coordinating responses to audit observations with the project team and ensuring customers receive responses within 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
- Agreeing on appropriate CAPAs and monitoring implementation to a satisfactory conclusion
- Supporting QA management during regulatory inspections
- Organizing preparation meetings and SME trainings
- Supporting Front Office/Back Office as required
- Responsible for QA aspects of paper inspections
- Coordinating with Regulatory Affairs to provide all required documents
- Answering queries from regulatory authorities with respect to paper inspections
Requirements
- Academic degree in Chemistry, Biotechnology, Life Sciences, or related field
- Excellent communication skills in English and German (fluency in both languages is required)
- Professional appearance and attitude to establish and maintain excellent working relationships 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 (e.g. MS Office) is required
- Experience in auditing chemical/biopharmaceutical processes is an asset
Benefits
- An agile career and dynamic working culture
- An inclusive and ethical workplace
- Compensation programs that recognize high performance
- A variety of benefits dependent on role and location
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