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:
QA Representative, CSV for MES (Ref. 2495) - 6 months contract
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.