Quality Compliance Specialist

In this position you will take part in preparations for audits and inspections. You will work with Quality documentation and you will be responsible for reporting on quality standards, deviations and CAPAs.

• Participation in continuous improvement of effectiveness and compliance in all GMP areas
• Implementing new GMP regulations and compile or update SOPs defining these regulations
• Supporting deviations’ investigations, corrective and preventive actions, implementation of changes and change control management
• Assisting in preparation of Polpharma Biologics for pharmaceutical inspections and audits conducted by national and international regulatory bodies
• Performing regular compliance checks in GMP areas
• Ensuring that all corrective actions after internal and external audits are effective and verified
• Monitoring internal audit non-conformances, performing trend analyses, and presenting findings
• Contact and cooperation with domestic and foreign regulatory bodies

• University degree (Biology, Chemistry, Pharmacy, Biotechnology or similar)
• Min. 3 years of working experience in pharmaceutical industry
• Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically to biopharmaceuticals
• Knowledge of Quality Management Systems, with specific understanding of deviations management, investigations and corrective/preventive actions as a general tool in the areas
• Ability to make decisions
• Ability to work as a team
• Ability to interpret and apply domestic and international regulations
• Fluent Polish, written and spoken
• Fluent English, written and spoken