Senior Qualifying Specialist

Panda International; Oberwallis; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Panda International in Switzerland seeks an experienced CQV specialist to lead commissioning, qualification and validation activities within a GMP-regulated environment. You will develop CQV documentation, perform PQ, and provide ongoing SLC support across projects with internal teams and external providers.

The role requires hands-on CQV expertise, strong documentation, and the ability to defend qualification outcomes during audits and inspections. German and/or English proficiency is essential.

Qualifikationen

• Experience in GMP-regulated pharma/biotech CQV.
• Proven CQV with PQ and CV documentation.
• Strong documentation discipline and audit readiness.

Aufgaben

• Develop and maintain CQV documentation for new plants, facilities and equipment.
• Prepare and execute qualification activities, including PQ for critical systems.
• Provide ongoing System Lifecycle (SLC) support after implementation and qualification.
• Manage deviations, CAPA, change control within GMP.
• Coordinate qualification activities with internal teams and external providers.
• Present and defend qualification documentation during audits and regulatory inspections.
• Support continuous improvement of qualification processes and equipment lifecycle management.
• Independently identify and resolve qualification-related issues while maintaining timelines.

Kenntnisse

CQV

GMP

CAPA

Deviation mgmt

PQ

SLC

Ausbildung

HF/FH or equivalent

Tools

SAP

COMOS

DMS

TrackWise

MS Office

Jobbeschreibung

Environment: GMP-regulated Pharmaceutical / Biotech Manufacturing

Key Responsibilities

• Develop and maintain Commissioning & Qualification (C&Q) documentation for new plants, facilities and process engineering equipment.
• Prepare and execute qualification activities, including Performance Qualification (PQ) for critical systems.
• Provide ongoing System Lifecycle (SLC) support following implementation and qualification.
• Manage and resolve deviations associated with commissioning, qualification and validation activities.
• Manage GEP and GMP changes and ensure activities are completed in accordance with applicable quality requirements.
• Define, coordinate and implement CAPAs effectively.
• Support the qualification and validation of critical equipment and systems, including refrigerators, freezers, clean media/utilities and process engineering equipment.
• Coordinate qualification activities between internal project teams, external service providers, vendors and equipment suppliers.
• Ensure qualification documentation is complete, accurate and inspection-ready.
• Present and defend qualification documentation during audits and regulatory inspections.
• Support continuous improvement initiatives relating to qualification processes and equipment lifecycle management.
• Independently identify and resolve qualification-related issues while ensuring project timelines and compliance requirements are maintained.
• Degree from a technical school (HF), University of Applied Sciences (FH), university or equivalent technical qualification.
• Proven professional experience within a regulated GMP environment.
• Strong hands-on experience with Commissioning, Qualification and Validation (CQV) activities.
• Experience qualifying systems and equipment such as refrigerators, freezers, clean media/utilities and/or process engineering equipment.
• Experience developing and maintaining qualification documentation.
• Experience with Performance Qualification (PQ) activities.
• Knowledge of deviation management, change control and CAPA within a GMP environment.
• Ability to work independently and take ownership of assigned qualification activities.
• Strong communication and coordination skills when working with internal teams, vendors and external service providers.
• Structured and detail-oriented approach to documentation and project execution.
• Proficiency in German and/or English, both written and spoken.
• Strong working knowledge of MS Office.

Preferred Requirements

• Previous experience supporting new plant, facility or equipment implementation/qualification projects within pharmaceutical or biotechnology manufacturing.
• Experience with System Lifecycle (SLC) activities following implementation.
• Experience presenting or defending qualification documentation during audits and inspections.
• Familiarity with COMOS.
• Familiarity with DMS/document management systems.
• Experience with TrackWise for quality processes.
• Experience using SAP.
• Experience coordinating multiple external suppliers and service providers.
• Proactive problem-solving approach with the ability to adapt quickly to changing project requirements.