Deviation Specialist II (Quality Assurance)

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

Deviation Specialist II | GMP Investigations

Job Description

A global life sciences organisation is seeking a Deviation Specialist to join its 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)

Project: Large-scale mammalian cell culture manufacturing facility

Industry: Biotechnology / Pharmaceutical Manufacturing

Function: Operations Quality / Deviation Management