QA Representative, Equipment Commissioning and Qualification (Ref. 2496) - 6 months contract

Your main tasks

• Support CAPEX projects from a QA perspective
• Act as Quality Validation representative for site and global project implementations
• Provide 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 to ensure conformance to cGxPs, guidance documents, or applicable industry accepted 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 equipment and systems 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
  • Develop and implement training programs on production lines and associated processes for QA ops team.
• 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
• Experience in qualification/validation of equipment/system or processes.
• 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.