Senior GMP QA Specialist

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

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.