Responsibilities:
- Prepare specifications for: - Materials used in the manufacture of medicated products - Primary and secondary packaging materials:
- Raw materials and excipients used
- Bulk products and finished products
- Initiates and configures specifications in LIMS system (Packaging Materials, Raw Materials and Excipients, Finished and Bulk Product, Stability Studies)
- Verifies and evaluates specifications in accordance with the internal workflow and documentation submitted to the authorities in the registration file for internally produced finished products and for testing and release at European level; Maintain and update revisions and quality documentation, change control actions in agreement with the approval of variations for finished products;
- It carries out the compliance process in accordance with internal procedures and applicable to products and files submitted to the authorities.
Requirements
- University studies in Chemistry, Biochemistry, Pharmacy;
- Professional experience in managing quality documentation or registering pharmaceuticals and / or quality assurance are a plus;
- PC knowledge (Microsoft Office - Excel, SAP, databases);
- English Language - medium level;
- Very good communication and interpersonal skills.