Quality Assurance GMP Switzerland

Resourcing Life Science Ltd.; Schweiz; Sur place; CHF 120 000 - 160 000; Plein temps

Résumé du poste

Resourcing Life Science Ltd. is seeking a seasoned Quality Assurance professional to oversee GMP compliance, review and update quality documents, and drive CAPA actions across manufacturing and quality operations.

You will assess batch documentation, investigate quality incidents, and coordinate corrective actions in collaboration with cross-functional teams. The role emphasizes auditing readiness, documenting findings, and promoting a strong quality culture throughout the organization to ensure

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific or technical discipline.
• At least 5 years of Quality Assurance experience in GMP-regulated pharma/biotech environments.
• Practical knowledge of GMP requirements, audit processes, deviation management and CAPA systems.

Responsabilités

• Maintain GMP compliance across manufacturing processes and finished products.
• Review and update SOPs and quality documentation for daily operations.
• Assess production/batch documentation for accuracy and compliance.

Connaissances

GMP Compliance

CAPA

Audits

Deviation Management

Documentation

Formation

Bachelor/Master in Life Science

Outils

QMS software

CAPA tracking system

Deviation management tools

Description du poste

Your responsibilities

• Maintain compliance with GMP requirements and applicable quality regulations across manufacturing processes and finished products.
• Review, develop and update SOPs, work instructions and quality documentation, ensuring these are followed consistently in daily operations.
• Assess production and batch documentation for accuracy and compliance, taking appropriate action when products do not meet release requirements.
• Investigate quality incidents and deviations, work with relevant departments to identify root causes, and ensure corrective and preventive actions are implemented effectively.
• Manage customer complaints, oversee investigations and coordinate the implementation of appropriate CAPAs.
• Plan and perform internal audits, document findings and ensure agreed improvements are completed.
• Coordinate external audits and inspections by customers and regulatory authorities, including preparation, responses and follow-up activities.
• Compile annual product quality reviews, assess quality system performance and prepare required reports and management information.
• Support quality-related discussions with internal teams and external partners, including the preparation and review of quality agreements.
• Advise production teams on quality requirements, promote GMP awareness and encourage a strong quality culture throughout the organization.
• Identify opportunities to improve Quality Assurance processes, monitor relevant KPIs and contribute to departmental performance reporting.

Your profile

• A bachelor’s or master’s degree in a relevant scientific or technical discipline.
• At least five years of Quality Assurance experience / GMP-regulated environment in pharma / biotech
• Practical knowledge of GMP requirements, audit processes, deviation management and CAPA system