GxP Planning & CAPA Specialist

Merck; Schachen; On-site; CHF 90,000 - 130,000; Full time

Job summary

Merck is seeking a Specialist in Planning & Scheduling within Global Clinical Supply to support GxP Quality System activities, ensuring compliant, inspection-ready clinical supply operations across phases I–IV in a fast-paced matrix environment.

The role emphasizes deviations, CAPA, and data integrity, with opportunities to grow in change control, documentation, training, audits, and risk management under established governance.

Qualifications

• Bachelor's degree in a Scientific, Engineering, or related field with 1+ years in a regulated GxP environment.
• Experience supporting GxP Quality System processes (deviations, CAPA, change control, documentation, training, audits/inspections, risk management, safety).
• Experience working within cross-functional teams in a regulated environment.
• Foundational understanding of GxP and ALCOA+ principles, with data integrity expectations.
• Ability to identify risks to compliance execution and elevate appropriately.
• Ability to support deviation investigations and CAPA activities with accurate documentation.
• Ability to collaborate effectively with stakeholders across organizations.
• Analytical skills to review data, support trending, and contribute to performance monitoring.

Responsibilities

• Support QMS execution, issue resolution, and continuous improvement across GCS.
• Assist with deviations, CAPA, change control, and documentation activities.
• Collaborate with Operations Planning, Quality, IT/Digital, and other teams to uphold compliance.
• Contribute to audits/inspections readiness and risk management efforts.

Skills

Adaptability

Analytical Thinking

CAPA Investigations

Investigations

Cross-Functional Communications

Data Analysis

Continuous Improvement

Education

Bachelor's degree in Scientific/Engineering field

Tools

MEDs

Veeva

TrackWise

LMS

Job description

Merck is seeking a Specialist in Planning & Scheduling within Global Clinical Supply to support GxP Quality System activities, ensuring compliant, inspection-ready clinical supply operations across phases I–IV in a fast-paced matrix environment.

The role emphasizes deviations, CAPA, and data integrity, with opportunities to grow in change control, documentation, training, audits, and risk management under established governance.