Strona główna

In this role, you will have an opportunity to take part in the whole life cycle of biopharmaceutical product development and production. You will be responsible for quality oversight over the sterile manufacturing including deviation, CAPA, change management, risk assessment, batch documentation review, and preparation for audits and inspections.

• Ensuring quality oversight over the sterile manufacturing area
• Ensuring cGMP and regulatory compliance of operations leading to biological Drug Product
• Ensuring that a high quality of products is achieved through qualification and validation based on quality risk analyses, product quality assessments, and ongoing verification
• Ensuring that all processes and products at the site meet all internal and external requirements
• Batch records’ and all related documentation review
• Participation in investigations on deviations and complaints, OOS/OOT, recalls and escalations
• Supporting change control requests, assuring GMP and regulatory compliance
• Participation in risk assessments
• Supporting all product and process-related activities e.g. process transfers, process validations, and continuous process verification (including e.g. stability studies, hold time studies, approval of protocols and reports)
• Supporting the preparation of Annual Product Quality Reviews
• Participation in internal and external audits
• Support establishment of Quality Management System documentation in accordance with the requirements of Polpharma Biologics and the HA requirements in reference to diverse market areas
• Ensuring correctness and data integrity of all regulatory and manufacturing data