Quality Assurance Specialist

BioTalent; Dortmund; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

BioTalent is seeking an experienced QA professional to support and continuously improve the Quality Management System within a regulated life sciences environment. This hands-on role focuses on ensuring compliance, driving quality standards, and supporting operational excellence across the business.

The successful candidate will manage deviations, change controls, CAPAs, and investigations, while coordinating audits and training activities to maintain readiness and compliance with GxP

Qualifikationen

• Experience in QA within a regulated pharmaceutical, biotech, CRO, CDMO, or life sciences environment.

Aufgaben

• Maintain, develop, and continuously improve the Quality Management System (QMS).
• Create, review, update, and manage quality documentation and procedures.
• Manage deviations, change controls, CAPAs, and investigations through to completion.
• Plan, coordinate, and monitor quality training activities across the organisation.
• Support qualification and validation activities ensuring compliance with internal and regulatory requirements.
• Review analytical testing documentation and quality records.
• Prepare for and participate in audits and inspections.
• Support audit findings, corrective actions, and continuous improvement initiatives.

Kenntnisse

Quality Assurance

GxP knowledge

Audits

CAPA management

Stakeholder management

Jobbeschreibung

Our client is seeking an experienced QA to support and continuously improve their Quality Management System within a regulated life sciences environment. This is a hands-on quality role focused on ensuring compliance, driving quality standards, and supporting operational excellence across the business.

Key Responsibilities

• Maintain, develop, and continuously improve the Quality Management System (QMS).
• Create, review, update, and manage quality documentation and procedures.
• Manage deviations, change controls, CAPAs, and associated investigations through to completion.
• Plan, coordinate, and monitor quality training activities across the organisation.
• Support qualification and validation activities, ensuring compliance with internal and regulatory requirements.
• Review analytical testing documentation and quality records.
• Prepare for and participate in customer, regulatory, and internal audits and inspections.
• Support audit findings, corrective actions, and continuous improvement initiatives.

Requirements

• Experience working within Quality Assurance in a regulated pharmaceutical, biotech, CRO, CDMO, or life sciences environment.
• Strong knowledge of Quality Management Systems and GxP requirements.
• Experience managing deviations, CAPAs, change controls, and quality investigations.
• Audit preparation and inspection readiness experience.
• Excellent organisational, communication, and stakeholder management skills.
• Ability to work independently and manage multiple quality priorities.

This is an excellent opportunity to join a growing life sciences organisation and play a key role in maintaining quality and compliance standards across the business.