Quality Assurance Specialist for Pharmaceutical Projects

vor 2 Wochen


Neuenburg, Neuenburg, Schweiz gloor&lang AG Vollzeit

At gloor&lang AG, we are seeking an experienced Quality Assurance Specialist to join our team in supporting a significant ongoing investment project. As a key member of our Pharma Operations team, you will represent Quality in cross-functional project teams, ensuring that all quality aspects are managed efficiently and in compliance with global policies, SOPs, GMP standards, and regulatory requirements.

Job Description:
  • Serve as the Quality Validation representative for site and global project implementation.
  • Provide quality and compliance expertise for validation activities, including equipment, utilities, room qualification, and Computerized System Validation (CSV).
  • Collaborate with project teams to resolve quality issues and plan QA activities.

In this role, you will have the opportunity to work on transformative projects that shape the future of healthcare. Our client is a leading biopharmaceutical company, renowned for its globally recognized product portfolio.

Key Responsibilities:
  • Promote compliance with data integrity and computer system validation regulations.
  • Support the lifecycle of the strategic Quality Operations plan.
  • Develop and implement QA training programs for production lines and associated processes.
Qualifications:
  • Proven experience in Quality Validation, specifically in pharmaceutical or biopharmaceutical environments.
  • Expertise in CAPEX projects, equipment, utilities, and process validation.
  • Familiarity with cGxPs, regulatory guidance, and industry standards.


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