QA Project Manager (f/m/d)

We are looking for a new team member...

General QA functional responsibilities

• Support continuous improvement programs to establish an effective QMS
• Represent QA in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project-/Site Engineering project/technology transfer to effectively execute tasks related to Drug Product processes
• Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions in line with current local SOPs
• Author, review and approve GMP-relevant documents and SOPs
• Present Drug Product QA topics during the conduction of customer audits and regulatory inspections within DP
• Participate in internal audits as required by the organization

Project-specific QA responsibilities within Drug Product

• Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations
• Support and approve project/product specific risk assessments
• Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
• Review and approve executive batch records, prepare batch release for the responsible person (FvP), including recommendation on disposition status

QA responsibilities for customer contact

• Customer contact in regards to QA topics. Support and manage interactions in cases of changes, deviations, technical complaints, out of specification results and others

QA responsibilities for release

• Delegate of FvP for Batch Disposition of DP
• Delegate of FvP for conditional release according to CHVI-4553 and CHVI-265873
• “Zuständigkeiten von Sonderfreigaben”

General information

• Startdate: June 2025
• Planned duration : until end of 2025
• Place of work: Visp
• Workload: 100%

If you are interested in this position, please send your resume in English.