Quality Assurance Engineer

Teoresi Group; Genf; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Teoresi Group in Geneva, Switzerland, seeks a Quality Assurance professional to support QMS, ensure GMP compliance, and drive continuous improvement across the product lifecycle.

You will work with cross-functional teams including Manufacturing, Engineering, Validation, and Regulatory Affairs to uphold quality standards and regulatory requirements.

The role requires a strong background in Life Sciences and hands-on experience with deviation management, CAPA, and audits.

Qualifikationen

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or related field.
• Minimum 5 years of experience in a Quality role within Pharma, Biotechnology, or Life Sciences.
• Strong knowledge of GMP regulations and quality systems.
• Experience with deviations, CAPA, change control, risk management, and audits.
• Familiarity with international regulatory requirements and quality standards.
• Professional proficiency in English.

Aufgaben

• Support and maintain QMS processes in compliance with GMP and applicable regulatory requirements.
• Manage and contribute to deviation investigations, CAPA implementation, change controls, and risk assessments.
• Participate in internal and external audits, inspections, and supplier qualification activities.
• Review and approve quality documentation, including SOPs, protocols, reports, and quality records.
• Ensure compliance with pharmaceutical regulations, company procedures, and industry best practices.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, and other stakeholders to drive quality initiatives.

Kenntnisse

Quality Assurance

GMP knowledge

CAPA

Deviation investigations

Audit processes

Risk management

Regulatory knowledge

English proficiency

Ausbildung

Bachelor's or Master's degree in Life Sciences/Pharmacy/Chemistry/Biotechnology/Engineering

Tools

QMS software

Deviation tracking tools

Jobbeschreibung

to support leading pharmaceutical projects within a dynamic and highly regulated environment. This role offers the opportunity to contribute to quality assurance and compliance activities across the pharmaceutical product lifecycle, ensuring adherence to GMP standards and regulatory requirements while collaborating with cross-functional international teams.

Responsibilities

• Support and maintain Quality Management System (QMS) processes in compliance with GMP and applicable regulatory requirements.
• Manage and contribute to deviation investigations, CAPA implementation, change controls, and risk assessments.
• Participate in internal and external audits, inspections, and supplier qualification activities.
• Review and approve quality documentation, including SOPs, protocols, reports, and quality records.
• Ensure compliance with pharmaceutical regulations, company procedures, and industry best practices.
• Collaborate with Manufacturing, Engineering, Validation, Regulatory Affairs, and other stakeholders to drive quality initiatives.

Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, Engineering, or a related field.
• Minimum 5 years of experience in a Quality role within the Pharmaceutical, Biotechnology, or Life Sciences industry.
• Strong knowledge of GMP regulations and quality systems.
• Experience with deviations, CAPA, change control, risk management, and audit processes.
• Familiarity with international regulatory requirements and quality standards.
• Professional proficiency in English.