Manager, Quality Assurance Compliance & Validation

Quality Assurance

Thörishaus (Berne) Switzerland

Summary Description
The Manager Quality Assurance Compliance & Validation is responsible for managing compliance of quality systems processes, which includes qualification, validation, risk management, hygiene and monitoring. With working place in Thörishaus (Berne) we want to strengthen our Quality Assurance (QA) team with a Manager QA Compliance & Validation (100%).

Main responsibilities:

  • Ensures that the allocated quality management systems are compliant with regulatory expectations
  • Participates in projects representing QA
  • Establishes and updates quality procedures and work instructions
  • Reviews and approves user specification requirements, qualification/ validation plans and reports and work instructions
  • Participates in risk management, critical process parameter and critical quality attributes identification
  • Supports and oversees the operational areas in the implementation of quality requirements and improvement measures
  • Participates in audits and health authority inspections
  • Performs review of environmental and utilities monitoring data
  • Provides input to annual product quality reviews
  • QA release of equipment for GMP use

Qualification requirements:

  • Minimum of Bachelor of Science (BS) required in scientific field
  • Minimum of 3 years relevant experience in the GMP regulated environment (FDA and Swissmedic)
  • Solid IT skills including MS Office required
  • High flexibility and strong problem solving skills to meet quality and business objectives
  • Multilingual – at least German and English, written and spoken