Quality Assurance Specialist

2 weken geleden

Stein, Nederland Pharmiweb Voltijd

Job Title: QA Specialist

Job Type: Contract

Location: Stein, Switzerland

Job Summary:

We are seeking a highly skilled QA Specialist to join our team at Pharmiweb. The successful candidate will be responsible for ensuring the qualification and validation compliance of equipment and computerized systems.

Key Responsibilities:

  • Oversee compliance for commissioning and qualification of large CAPEX projects from ideation through execution.
  • Approve SOPs, commissioning/qualification/validation protocols, reports, and project-related CQV/CSV documents.
  • Provide QA leadership, oversight, and support on qualification/validation topics for ongoing projects, ensuring vendor qualification.
  • Serve as the primary contact within GQE for lifecycle and compliance matters related to equipment, infrastructure, and computerized systems qualification/validation.
  • Manage quality deviations, changes, and CAPAs/tasks promptly, taking leadership for resolution and escalating when necessary.

Requirements:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • Significant experience in the GMP-regulated pharmaceutical industry, preferably within a Quality Unit.
  • Experience in a QA role for CSV/Automation of GMP systems related to aseptic fill-finish processes and facilities.
  • Fluency in English; German proficiency is an advantage.

About Us:

Pharmiweb is a leading provider of pharmaceutical services. We are committed to delivering high-quality solutions to our clients.

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