For our client, a leading and innovative pharmaceutical company with its international headquarter based in the French part of Switzerland, we are searching for a:
Your main tasks
* Act as Quality Validation representative for site and global project implementations
* Provide QA support for Computerized System Validation (CSV) to ensure compliance with cGxPs and industry standards
* Collaborate with project teams to resolve quality issues and organize QA activities
* Ensure effective communication among project stakeholders and within QA, implementing necessary processes
* Review and approve qualification/validation documents, including design specs, test plans, protocols, and reports
* Evaluate and approve deviations, incidents, and changes during system qualification/validation
* Assist with drafting and reviewing procedural documents prepared by SMEs
* Promote compliance with data integrity and CSV requirements
* Participate in the site’s strategic Quality operations plan and support evaluation of change controls, deviations, and risk assessments
* Ensure EHS compliance and promote safe work practices
Your profile
* Minimum 5 years 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 French and English
* Works independently and effectively in cross-functional teams
* Strong problem-solving, risk mitigation, and critical thinking skills
* High sense of ethics, discretion, and diplomacy
* University degree in science preferred
* Proficient in English and French
Sebastian Pal is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).
Full discretion is guaranteed and we will gladly answer any additional questions.
AurigaVision AG
Herr Sebastian Pal
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