Quality Assurance GMP Denmark

Resourcing Life Science Ltd.; Denmark; On-site; DKK 650,000 - 850,000; Full time

Job summary

Resourcing Life Science Ltd. in Denmark is seeking a seasoned Quality Assurance professional to uphold GMP compliance across manufacturing processes and finished products while driving robust quality governance and documentation.

You will review SOPs, lead internal and external audits, manage CAPAs, investigate incidents and support quality discussions with cross-functional teams to uphold the highest standards of product quality and regulatory readiness.

Qualifications

• Requires bachelor’s or master’s degree in a relevant scientific or technical discipline.
• Minimum five years of Quality Assurance experience in a GMP-regulated pharma/biotech environment.
• Practical knowledge of GMP requirements, audits, deviation management and CAPA.

Responsibilities

• Maintain GMP compliance across manufacturing processes and finished products.
• Review and update SOPs, work instructions and quality documents.
• Assess production and batch documentation for accuracy and compliance.
• Investigate quality incidents, identify root causes and implement CAPAs.
• Manage customer complaints and coordinate investigations.
• Plan and perform internal audits and document findings.
• Coordinate external audits by customers and regulators.
• Prepare annual product quality reviews and reports.
• Support quality discussions with internal teams and partners, including quality agreements.
• Advise production teams on quality requirements and promote GMP culture.
• Identify opportunities to improve Quality Assurance processes and monitor KPIs.

Skills

Quality Assurance

GMP knowledge

Audit experience

Education

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

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