In this role, you will oversee compliance and customer quality agreement activities for drug product operations. You will collaborate closely with various teams to establish and negotiate quality agreements, serve as a point of contact for quality assurance inquiries, and manage interactions related to changes and complaints. This position requires a proactive approach to ensure effective execution of drug product processes while maintaining high-quality standards.

Place of Work: Visp

Project Duration: Approx. 8 Months

Starting Date: 01/05/2025

Key Responsibilities
 

  • Supervise compliance and customer quality agreement activities for drug product operations
  • Establish and negotiate quality agreements in collaboration with relevant teams
  • Serve as the primary point of contact for quality assurance-related inquiries and complaints from customers
  • Manage interactions regarding changes, deviations, technical complaints, and out-of-specification results
  • Represent quality assurance in cross-functional teams and maintain effective interfaces with manufacturing, quality control, and engineering teams
  • Act as the quality assurance representative in project teams and customer meetings during technical transfers
  • Support and facilitate project-specific risk assessments and regulatory gap assessments
  • Review and release product-specific documentation, including process descriptions, manufacturing protocols, and test plans
  • Collaborate closely with quality control project leaders and support new product introductions
  • Assess, review, and approve quality records such as deviations, change controls, and corrective actions
  • Author, review, and approve GMP-relevant documents and standard operating procedures

Candidate Profile

  • 5-10 years of relevant work experience in quality assurance (or related fields)
  • Strong understanding of quality management systems and regulatory requirements
  • Ability to manage multiple projects and priorities in a fast-paced environment
  • Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams
  • Languages: Proficiency in English is mandatory, German is a plus