Senior Quality Assurance Specialist for MES Validation
Vor 3 Tagen
AurigaVision AG seeks a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the validation and qualification of computerized system validation (CSV) processes in accordance with current Good Manufacturing Practice (cGxP) regulations.
Main Responsibilities:
- Collaborate with project teams to ensure quality standards are met throughout site and global project implementations.
- Provide QA support for CSV to guarantee compliance with cGxPs and industry standards.
- Evaluate and approve qualification/validation documents, including design specs, test plans, protocols, and reports.
- Assist in the development and review of procedural documents prepared by subject matter experts.
- Promote data integrity and CSV requirements within the organization.
Requirements:
- Minimum 5 years of QA or QC experience in pharmaceuticals or regulated industries.
- Strong knowledge of cGMPs, Swiss, EU, and FDA regulations, MES, and SAP.
- Proficient in Change Control, Deviation Management, and Risk Management.
- Excellent analytical, communication, and interpersonal skills in English and French.
- Ability to work independently and effectively in cross-functional teams.
What We Offer:
- Opportunity to work with a dynamic and innovative company.
- Challenging role that requires expertise and analytical skills.
- Frequent opportunities for professional growth and development.
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