Strona główna

Key element of the role is to ensure that production and quality control areas are compliant with the rules and procedures in place at Polpharma Biologics. You will be responsible for preparation of the department documentation and revision of documentation prepared by other parties. You will be also tasked with assessment of changes, investigations, and deviations process management, and with performing of risk assessments within the assigned area. You will also perform revisions of handwritten and audit trails records referred to drug substance manufacturing process and testing.

• Preparation and reviewing of GMP documents, including review of Batch Records;
• Assessment of the documentation both internal and provided by the external parties;
• Participation in inspections of the pharmaceutical authorities and customer audits, to the extent specified by the supervisor;
• Participation in internal audits;
• Participation in the processes of change control, risk analysis and deviation, including investigations and verification of the CAPA in accordance with the applicable procedures;
• Verification of production processes for compliance with GMP requirements through regular visits at the production area;
• Supporting the whole life cycle management of a manufacturing facility, up to and including GMP compliant market production;
• Supporting preparation of Annual Product Quality Reviews.