Quality Assurance GMP Germany

Resourcing Life Science Ltd.; Deutschland; On-site; EUR 70,000 - 100,000; Full time

Job summary

Resourcing Life Science Ltd. is seeking a Quality Assurance professional to uphold GMP compliance across manufacturing and finished products. The role includes reviewing SOPs, ensuring documentation integrity, and driving CAPA initiatives.

The candidate will lead investigations into quality incidents, coordinate internal and external audits, and produce annual quality reviews to support continuous improvement and regulatory readiness.

Qualifications

• Bachelor’s or Master’s degree in a relevant scientific or technical discipline.
• Minimum five years of QA experience in a GMP-regulated pharma/biotech.
• Hands-on knowledge of GMP requirements, audits, deviation management and CAPA.

Responsibilities

• Maintain compliance with GMP requirements and quality regulations across manufacturing processes and finished products.
• Review, develop and update SOPs, work instructions and quality documentation and ensure daily adherence.
• Assess production and batch documentation for accuracy and compliance, taking appropriate action for release failures.
• Investigate quality incidents and deviations, identify root causes and implement corrective actions.
• Manage customer complaints, oversee investigations and coordinate CAPA implementations.
• Plan and perform internal audits, document findings and drive improvements.
• Coordinate external audits by customers and regulatory authorities, including responses and follow-ups.
• Compile annual product quality reviews and report on quality system performance.

Skills

GMP knowledge

Quality Assurance

Document control

Education

Bachelor's or Master's in life sciences

Tools

CAPA system

Job description

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