Deviation Specialist

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

Zusammenfassung

Panda International in Visp, Switzerland, seeks a Deviation Specialist II to join its GMP Investigations team within the BioAtrium manufacturing project. You will own deviation investigations, identify root causes, assess product and system impact, and drive CAPAs through to completion.

You will collaborate with SMEs and cross-functional stakeholders to ensure investigations meet cGMP requirements while contributing to continuous improvement initiatives in a regulated biotech environment.

Qualifikationen

• Bachelor's degree in Chemistry, Biotechnology, Life Sciences or related field.
• Experience in deviation investigations within regulated pharma or API env is an 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 (Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, 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 (written and spoken).

Aufgaben

• Take ownership of quality deviations and lead investigations from start to completion.
• Identify root causes, assess product and system impact, and drive CAPAs.
• Collaborate with SMEs and cross-functional stakeholders while ensuring cGMP compliance.

Kenntnisse

Quality investigations

Root cause analysis

Cross-functional collaboration

cGMP knowledge

CAPA definition

Investigations documentation

Technical writing

English proficiency

Ausbildung

Chemistry/Biotechnology/Life Sciences degree

Jobbeschreibung

Deviation Specialist II | GMP Investigations

Job Description

A global life sciences organisation is seeking a Deviation Specialist to join its BioAtrium manufacturing project in Visp, Switzerland. This position will support a large-scale mammalian cell culture facility by taking ownership of quality deviations, leading investigations, identifying root causes, assessing product and system impact, and driving corrective and preventive actions (CAPAs) through to completion.

In this role, you will represent the Operations Unit, collaborate with Subject Matter Experts (SMEs) and cross-functional stakeholders, and ensure investigations are conducted in accordance with cGMP requirements. You will contribute to continuous improvement initiatives while maintaining compliance and supporting manufacturing operations within a regulated biotechnology environment.

• 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

Preferred Requirements

• Experience within biotechnology manufacturing processes and analytical methods
• Experience with Human and Organizational Performance (HOP) and risk management approaches
• German language skills are an advantage
• Structured, focused, and well-organised working style
• Open-minded, agile, highly motivated, and adaptable approach to work
• Experience supporting process improvement and continuous improvement initiatives within manufacturing environments

Practicalities

Start Date: ASAP

Location: Visp, Switzerland (fully onsite)

Industry: Biotechnology / Pharmaceutical Manufacturing

Function: Operations Quality / Deviation Management