Senior Quality Assurance Specialist for Equipment Commissioning and Qualification
Vor 2 Tagen
AurigaVision AG is seeking an experienced Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will play a crucial role in ensuring the compliance of our equipment commissioning and qualification processes with regulatory requirements.
Key Responsibilities- SUPPORTING CAPEX PROJECTS: Collaborate with project teams to ensure quality assurance standards are met during CAPEX projects from a QA perspective.
- QUALITY VALIDATION REPRESENTATIVE: Act as the Quality Validation representative for site and global project implementations, providing quality and compliance support for validation activities associated with equipment qualification, utilities qualification, room qualification, and/or computerized system validation experience (CSV), cleaning validation, and/or process validation.
- DOCUMENT REVIEW AND APPROVAL: Review and approve qualification/validation documents, including design specs, test plans, protocols, and reports, to ensure they meet regulatory requirements.
- DEViation MANAGEMENT: Evaluate and approve deviations, incidents, and changes during equipment and systems qualification/validation.
- TRAINING PROGRAMS: Develop and implement training programs on production lines and associated processes for QA ops team members.
- EHS COMPLIANCE: Ensure EHS compliance and promote safe work practices throughout the organization.
- MINIMUM 5 YEARS QA OR QC EXPERIENCE: Proven experience in quality assurance or quality control in pharmaceuticals or regulated industries.
- REGULATORY KNOWLEDGE: Strong knowledge of cGMPs, Swiss, EU, and FDA regulations, MES, and SAP.
- EXPERTISE IN QUALIFICATION/VALIDATION: Experience in qualification/validation of equipment/systems or processes.
- SKILLS: Proficient in Change Control, Deviation Management, and Risk Management, with excellent analytical, communication, and interpersonal skills in English and French.
- INDEPENDENT WORKER: Ability to work independently and effectively in cross-functional teams, with strong problem-solving, risk mitigation, and critical thinking skills.
- UNIVERSITY DEGREE: University degree in science preferred.
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