GMP Deviation Investigator II | CAPA & Root-Cause Lead

Panda International; Oberwallis; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Panda International is seeking a Deviation Specialist II to join its GMP Investigations team in Visp, Switzerland. You will own deviation investigations, drive CAPAs, and ensure cGMP compliance across a large-scale mammalian cell culture manufacturing environment.

You will collaborate with SMEs and cross-functional stakeholders, document root causes, and implement robust corrective actions while contributing to continuous improvement initiatives within a regulated biotechnology setting.

Qualifikationen

• Bachelor's degree in Chemistry, Biotechnology, Life Sciences, or a related field.
• Experience in deviation investigations within a regulated pharmaceutical or API environment is a strong advantage.
• Knowledge of cGMP principles and quality investigation processes.
• Ability to own, author, document, and investigate quality deviations.
• Experience collaborating with SMEs and cross-functional stakeholders to determine root causes and business impact.
• Knowledge of structured investigation methodologies such as Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, and Fishbone Diagram.
• Experience defining CAPAs and associated effectiveness checks to prevent recurrence.
• Ability to drive quality records to timely completion while ensuring cGMP compliance.
• Strong technical writing, presentation, and communication skills.
• Fluency in English, both written and spoken.

Aufgaben

• Own and lead deviation investigations from initiation to CAPA closure.
• Collaborate with SMEs and cross-functional stakeholders to determine root causes and impact.
• Ensure investigations comply with cGMP requirements and quality records.
• Contribute to continuous improvement initiatives within manufacturing operations.

Kenntnisse

Quality investigations

CAPA processes

Technical writing

English language

Cross-functional collaboration

Ausbildung

Bachelor's degree in Chemistry, Biotechnology, Life Sciences

Jobbeschreibung

Panda International is seeking a Deviation Specialist II to join its GMP Investigations team in Visp, Switzerland. You will own deviation investigations, drive CAPAs, and ensure cGMP compliance across a large-scale mammalian cell culture manufacturing environment.

You will collaborate with SMEs and cross-functional stakeholders, document root causes, and implement robust corrective actions while contributing to continuous improvement initiatives within a regulated biotechnology setting.