GMP Asset Specialist - Calibration & Compliance

PerkinElmer; Lavamünd; Hybrid; EUR 96.000 - 138.000; Vollzeit

Zusammenfassung

PerkinElmer is seeking a Manufacturing Asset Specialist to support a customer site in Schachen, Switzerland. You will review, approve, and release calibration assets and work with engineers to ensure regulatory documentation aligns with GDocP expectations.

The role involves data management in CCMS/CMMS systems and adherence to cGMP standards, with a strong emphasis on accuracy and collaboration across teams.

Qualifikationen

• 3–5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles.
• Bachelor's degree in Life Sciences or Quality/Compliance.
• Knowledge of cGMP and validation regulations and requirements.
• Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements.
• Strong written and verbal communication in English; German preferred.

Aufgaben

• Document Review & Approval / Asset Release - Reviews and approves documents as part of calibration, maintenance, and repair work.
• Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDocP gaps in provided documentation.
• Releases assets after successful completion of calibration, maintenance, and repair work.
• Processes Changes, deviations, and CAPA related with calibration and maintenance.
• Contributes to changes and investigations as a member of cross-functional teams.
• Data Management / Administrative Release - Adds, updates, reviews, and releases asset records in the customer calibration/maintenance databases (CCMS/CMMS).
• Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems.

Kenntnisse

English

German

Communication

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences or Quality/Compliance

Tools

CCMS/CMMS

Jobbeschreibung

PerkinElmer is seeking a Manufacturing Asset Specialist to support a customer site in Schachen, Switzerland. You will review, approve, and release calibration assets and work with engineers to ensure regulatory documentation aligns with GDocP expectations.

The role involves data management in CCMS/CMMS systems and adherence to cGMP standards, with a strong emphasis on accuracy and collaboration across teams.