GMP Quality Assurance Lead (Pharma/Biotech)

Resourcing Life Science Ltd.; Polska; In loco; PLN 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Resourcing Life Science Ltd. is seeking a quality-focused professional to uphold GMP compliance across manufacturing and finished products. You will review SOPs, work instructions and quality documentation, and ensure they are followed in daily operations.

You will assess production documentation for accuracy, investigate incidents, drive CAPA actions, and coordinate internal and external audits. The role requires 5+ years in a GMP-regulated pharma/biotech environment and a strong quality

Competenze

• Bachelor’s or Master’s degree in a relevant scientific or technical field.
• Five years of QA experience in GMP-regulated pharma/biotech environments.
• Practical knowledge of GMP, audits, deviations, and CAPA systems.

Mansioni

• Maintain 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; take corrective actions as needed.
• Investigate quality incidents and deviations; drive root-cause analysis and CAPA.
• Manage customer complaints; oversee investigations and CAPA implementations.
• Plan and perform internal audits; document findings and drive improvements.
• Coordinate external audits and inspections by customers and regulators; prepare responses and follow-up.
• Compile annual product quality reviews and report on QMS performance.
• Support quality discussions with internal teams and external partners; review quality agreements.
• Advise production teams on quality requirements and promote GMP awareness.

Conoscenze

Quality Assurance

GMP

Audit

Deviation management

CAPA

Formazione

Bachelor's or Master's in a relevant scientific/technical discipline

Descrizione del lavoro

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