QA Compliance engineer, Comet QMS expert DE/EN (M/F/X)

About the Job

You provide operational support to engineering teams in pharmaceutical production environments, ensuring full compliance with GMP, internal standards, and established quality processes. Your main mission is to support, coordinate, and drive quality and risk assessment activities, primarily within the COMET quality system.

• Support creation, review, maintenance, and closure of NC and CoC records in COMET
• Prepare, moderate, and follow-up risk assessment workshops (logistics, agenda, technical materials)
• Ensure risk assessments meet all internal/GMP standards (structured methodology, documentation, clear action items)
• Track and follow up on open actions, proactive deadline monitoring, escalate when necessary
• Serve as strong interface to QA/QAE teams, ensuring alignment and immediate escalation in cases of major deviations
• Support successful audit/inspection outcomes with high-quality, accessible documentation
• Train and coach colleagues on COMET and risk assessment best practices
• Maintain accurate, up-to-date to-do lists and status overviews for GET management
• Collaborate with technical record owners and QA teams to ensure records are complete, accurate, and compliant
• Prepare and facilitate risk assessment meetings (agenda, technical inputs, documentation)
• Track action items, deadlines, and enforce timely completion of activities
• Report regular status updates to GET management and escalate deviations or risks
• Support audits and inspections by providing and explaining COMET records and risk assessments

About You

• University degree (BSc/MSc) in engineering, life sciences, or a comparable technical field
• Proven experience in GMP-regulated environments, ideally in pharmaceuticals, parenterals, packaging/optical inspection, utilities, or API/solids
• Practical experience with electronic quality management systems (COMET or similar QMS) and risk assessment methodologies (FMEA, HAZOP, etc.)
• Fluency in German, business-proficient English

EFOR Group’s legal entity, KALIPSIA AG is based at Holbeinstr. 50, 4051 Basel, is recruiting and managing client relationships. The recruitment is for assignments and projects carried out for our clients, as well as for company mandates.

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.

Do you want to join a dynamic and ambitious company? EFOR is made for you. Send your application to: kathleen.scherrer@efor-group.com