QA Representative, Equipment Commissioning and Qualification
Vor 2 Tagen
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.
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