Quality Assurance GMP Austria

Resourcing Life Science Ltd.; Osterreich; On-site; PEN 275,000 - 378,000; Full time

Job summary

Resourcing Life Science Ltd. is seeking a senior QA professional to maintain GMP compliance across manufacturing processes and finished products. You will review and develop SOPs, ensure documentation accuracy, and lead CAPA activities to drive continuous improvement.

The role requires in-depth GMP knowledge, audit experience, and the ability to coordinate with cross-functional teams to uphold quality standards and regulatory readiness.

Qualifications

• 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.

Responsibilities

• Ensure GMP compliance across manufacturing processes and finished products.
• Review and update SOPs, work instructions and quality documentation.
• Assess production and batch documentation for accuracy and compliance.

Skills

QA experience

GMP knowledge

Audit readiness

CAPA knowledge

Education

Bachelor’s or Master’s in a relevant scientific discipline

Tools

Quality management systems

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