GxP Validation & Compliance Specialist

PerkinElmer; Schweiz; Vor Ort; EUR 118.944 - 151.383; Vollzeit

Zusammenfassung

MSD Switzerland is seeking a Validation & Compliance Engineer to ensure GxP-compliant calibration, maintenance, and repair activities at a customer site. You will review documentation, manage CAPAs and deviations, and release assets for use.

You will collaborate with Calibration & Maintenance Engineers to sustain regulatory compliance, contribute to investigations, and maintain CCMS/CMMS records. Strong communication and attention to detail are essential.

Qualifikationen

• Bachelor's degree or equivalent in Life Sciences or Quality/Compliance. (preferred)
• Minimum 5 years in quality, validation or compliance in a (Bio-)Pharma company
• Knowledge of cGMP, Annex 1 and validation regulations

Aufgaben

• Review and approve documentation for calibration, maintenance, and repair activities
• Release assets for use and manage changes, deviations, and CAPAs
• Collaborate with Calibration & Maintenance Engineers to maintain GxP compliance
• Release assets after successful calibration, maintenance, and repair
• Process changes, temporary changes, deviations, and CAPA related to calibration and maintenance
• Contribute to changes and investigations as part of cross‑functional teams
• Add, update, review, and release positions in CCMS/CMMS databases
• Review and release calibration and maintenance entries in CCMS/CMMS systems

Kenntnisse

Quality Assurance

cGMP Knowledge

Regulatory Knowledge

Attention to Detail

Communication Skills

Teamwork

Customer Service Mindset

Documentation Skills

Ausbildung

Bachelor's degree in Life Sciences or Quality/Compliance

Jobbeschreibung

MSD Switzerland is seeking a Validation & Compliance Engineer to ensure GxP-compliant calibration, maintenance, and repair activities at a customer site. You will review documentation, manage CAPAs and deviations, and release assets for use.

You will collaborate with Calibration & Maintenance Engineers to sustain regulatory compliance, contribute to investigations, and maintain CCMS/CMMS records. Strong communication and attention to detail are essential.