QA - CQV/CSV Specialist

vor 17 Stunden

Stein am Rhein, Schaffhausen, Schweiz Panda International Vollzeit

Position: QA Specialist – CSV & Automation

Overview

The QA Specialist, CSV & Automation is responsible for ensuring full GMP compliance for the qualification and validation of equipment, computerized systems, infrastructure, and utilities supporting aseptic drug product manufacturing. This role supports large CAPEX projects across all lifecycle phases, from concept and design through commissioning, qualification, and validation.

Key Responsibilities

  • Ensure qualification and validation strategies are developed, implemented, and compliant with internal Quality policies.
  • Approve SOPs, commissioning/qualification/validation (CQV/CSV) protocols, reports, and project documentation, including URS, FAT, and SAT.
  • Provide QA leadership and oversight on all qualification and validation activities for equipment, utilities, infrastructure, and computerized systems.
  • Confirm that external vendors and suppliers meet qualification and compliance requirements.
  • Serve as QA point of contact for equipment and computerized system lifecycle activities, ensuring proper documentation within global quality systems (e.g., Kneat, TrackWise, DMS, Unifier).
  • Manage GMP deviations, change controls, CAPAs, and tasks, ensuring timely resolution and escalation when needed.

Requirements

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline.
  • Extensive experience in a GMP-regulated pharmaceutical environment, ideally within a Quality Unit.
  • Strong expertise in QA for CSV and automation systems for aseptic fill-finish operations (filling lines, lyophilizers, clean utilities, cleanroom environments).
  • Fluency in English; additional languages (such as German) are beneficial.

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