Deviations Specialist

KPC International; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Equal Opportunity Employer

Zusammenfassung

KPC International in Visp, Switzerland, is seeking a Deviation Specialist to own and investigate deviations at a large-scale mammalian cell culture facility. You will define root causes, assess impact on product and systems, and draft CAPAs to prevent recurrence while ensuring timely closure of quality records.

The role requires a Bachelor’s degree in chemistry, biotechnology, or life sciences, GMP experience in a regulated environment, and strong technical writing and communication skills.

Qualifikationen

• Bachelor’s degree in chemistry, biotechnology, life science or related field.
• GMP/cGMP in regulated pharma/API industry is an advantage.
• Fluency in English; German is an advantage.

Aufgaben

• Own, author, record and investigate Deviations.
• Liaise with SMEs to establish root causes and impact.
• Use investigative tools (FTA, DEF Analysis, fishbone diagram).
• Define CAPAs and effectiveness checks for deviations.
• Ensure cGMP compliance and timely closure of quality records.

Kenntnisse

Technical writing

Presentation/communication

Fluency in English

German language

Organizational skills

Ausbildung

Bachelor’s degree in chemistry, biotechnology, life science or related field

Jobbeschreibung

KPC International - Excellence from Concept to Completion

KPC International began operations in 2001. Our team of engineers and scientists has helped our clients achieve project success across the globe within the biologics industry.

We specialise in Plant Facility Start-Up, from Strategy and Planning through to Execution and Operational Readiness. We are proud to support our clients in delivering life-changing mAbs therapies to patients.

DEVIATION SPECIALIST

Location: Visp, fully onsite.

The Deviation Specialist will be part of a team that is currently established to own and investigate deviations at a large-scale mammalian cell culture facility.

He/she represents the Operations Unit, taking ownership of Deviations which arise; to investigate the root cause(s), the impact/potential impact on product and/or systems, and to define appropriate CAPA(s) as solutions.

KEY RESPONSIBILITIES

• Responsible to own, author, record and investigate Deviations.
• Liaise with Subject Matter Experts (SMEs) and key stakeholders to establish the root cause(s) of deviations and the potential impact of said deviations.
• Ensure proper investigational tools are used to systematically define the root cause(s) and contributing factor(s) (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.).
• Contribute to define appropriate CAPA(s), and associated Effectiveness Checks, as solutions to correct deviations and prevent future recurrence.
• Ensure cGMP compliance through the investigation process, and to drive their quality records to completion and timely closure.
• Support the business through ongoing change and process improvement activities.

SKILLS AND EXPERIENCE

• Bachelor’s degree in chemistry, biotechnology, life science or related field.
• Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry is a strong advantage.
• Knowledge of biotech. manufacturing processes and analytical methods is an advantage.
• Experience with Human and Organizational Performance & risk management approaches is an advantage
• Fluency in English, both written and spoken. German is an advantage.
• Technical writing & presentation/communication skills are key for the role. Demonstrated previous experience is a strong advantage.
• Structured, focused and well-organised working attitude. Open-minded for new ideas and suggestions; agile, highly motivated and dynamically driven.

Why Join KPC International?

If you're looking to contribute to a high-performing manufacturing environment where quality and compliance are at the heart of everything we do, we'd love to hear from you.

KPC International offers an inclusive environment where you can broaden your experience, perspective, and skills while helping make a meaningful impact on the lives of patients.

KPC International is an Equal Opportunity Employer.