GMP Validation & Cleaning Lead – Biotech QA SME (Onsite)

Real; Oberwallis; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Real is seeking an experienced QA Validation & Qualification/ Cleaning SME to ensure GMP-compliant validation activities across manufacturing, cleaning validation, equipment, and systems. The role supports product quality, regulatory compliance, and continuous improvement in Visp, on-site.

Key accountabilities include overseeing CPV and PV activities, SOP reviews, and documentation for regulatory audits. English required; German a plus; 5–7 years pharma GMP experience preferred.

Qualifikationen

• Bachelor’s degree in Science, Biotechnology, or related field.
• 5–7 years of pharma GMP experience.
• Strong knowledge of process and cleaning validation and equipment qualification.
• Experience with change controls, deviations, and non-conformity investigations.
• English proficient; German a plus.

Aufgaben

• Validate and maintain critical GMP processes in line with product requirements and regulatory guidelines.
• Collaborate with MSAT, Manufacturing, and clients to provide scientifically sound, documented evidence.
• Oversee validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Validate manual and automated cleaning and sanitization processes.
• Oversee qualification requirements of related equipment and systems.
• Manage CPV and process validation activities.
• Act as QA contact for product transfers and validation strategies.
• Review and approve validation documentation including PV, Cleaning PV, and CSV.

Kenntnisse

Process Validation

Cleaning Validation

Equipment Qualification

Deviation Management

Change Controls

CPV/PPQ

Validation Master Plan

CSV Documentation

Low Bioburden Environment

Ausbildung

Bachelor's degree in Science/ Biotechnology or related field

Jobbeschreibung

Real is seeking an experienced QA Validation & Qualification/ Cleaning SME to ensure GMP-compliant validation activities across manufacturing, cleaning validation, equipment, and systems. The role supports product quality, regulatory compliance, and continuous improvement in Visp, on-site.

Key accountabilities include overseeing CPV and PV activities, SOP reviews, and documentation for regulatory audits. English required; German a plus; 5–7 years pharma GMP experience preferred.