Quality Assurance Associate

Real; Bezirk Solothurn; Vor Ort; CHF 60.000 - 90.000; Teilzeit

Zusammenfassung

Real in Solothurn, Switzerland seeks a Quality Assurance Associate to support GMP-regulated operations in a biopharmaceutical setting. The role focuses on quality compliance, onboarding, and coordination across global stakeholders, at 80% workload.

You will help maintain the site QMS, assist with inspections and CAPA management, and ensure documentation reviews meet regulatory standards. This position is ideal for a junior quality professional looking to grow in a highly regulated manufacturing

Qualifikationen

• Must have GMP knowledge and practical experience in GMP-regulated environments.
• Solid understanding of Quality Management Systems and quality processes.
• Experience with CAPA management, deviations, and change controls.
• Excellent communication with global stakeholders.

Aufgaben

• Maintain and continuously improve the site QMS.
• Support GMP compliance activities and inspection readiness.
• Assist onboarding for employees, suppliers, and contractors.
• Coordinate quality governance meetings and track actions.
• Manage deviations, CAPAs, and change controls.
• Review quality documentation for compliance.
• Prepare quality metrics, reports, and KPI data.
• Support internal audits and inspections.
• Liaise with cross-functional teams across locations.
• Keep accurate records in electronic QMS.

Kenntnisse

GMP knowledge

Quality mindset

Strong organizational skills

Cross-functional communication

Fluent English

Ausbildung

Bachelor's degree in Life Sciences/Pharma

Quality Management certification

Tools

TrackWise

Oracle PLM

QMS software

Jobbeschreibung

Location: Solothurn, Switzerland
Contract Duration: ASAP until end of February 2027, with potential for extension
Workload: 80%

Position Overview

We are seeking a Quality Assurance Associate to provide immediate support within a GMP-regulated biopharmaceutical environment. Due to an urgent business need, the team is looking for someone who can join as soon as possible and contribute across a range of Quality Management System (QMS) activities.

This position is well suited to a relatively junior quality professional who already has a foundation in GMP regulations and quality processes and is looking to further develop their experience within a highly regulated manufacturing environment.

The successful candidate will support quality compliance activities, inspection readiness efforts, onboarding processes, supplier and contractor quality coordination, governance meetings, documentation review, reporting activities, and communication with global stakeholders.

Key Responsibilities

• Support the maintenance and continuous improvement of the site Quality Management System (QMS).
• Assist with GMP compliance activities and help ensure ongoing inspection and audit readiness.
• Provide quality support during onboarding activities for employees, suppliers, and contractors.
• Coordinate and support quality governance meetings, including agenda preparation, meeting minutes, action tracking, and follow-up.
• Assist with the management and tracking of deviations, CAPAs, change controls, and other QMS-related records.
• Review quality documentation to ensure compliance with internal procedures and regulatory requirements.
• Prepare, compile, and communicate quality metrics, reports, and KPI data.
• Support internal audits, inspections, and follow-up activities.
• Liaise with cross-functional and global teams to ensure timely completion of quality actions.
• Maintain accurate records within electronic quality management systems.

Required Qualifications

• Degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Quality Management, or a related field.
• Previous experience working within a GMP-regulated environment.
• Basic understanding of Quality Management Systems and quality processes.
• GMP requirements
• CAPA management
• Deviations
• Change Controls
• Inspection Readiness activities
• Strong organizational and communication skills.
• Ability to work effectively with stakeholders across different functions and global locations.
• Fluent English, both written and spoken.
• Proactive and detail-oriented working style.

Preferred Qualifications

• Experience within the biotechnology, pharmaceutical, or biopharmaceutical industry.
• Familiarity with quality systems such as:
• TrackWise
• Oracle PLM
• Experience supporting audits, inspections, governance boards, or quality review meetings.
• Exposure to quality reporting and KPI management.
• Strong attention to detail.
• Collaborative and team-oriented mindset.
• Comfortable working in a fast-paced, regulated environment.
• Ability to manage multiple priorities simultaneously.
• Self-driven with a willingness to take ownership of assigned activities.
• Strong interpersonal skills and confidence communicating with global stakeholders.