Junior software developer állások, munkák minőségbiztosítás kategóriában

• Perform analyses of finished products, samples in progress, raw materials, excipients, cleaning samples, validations and environmental monitoring according to established procedures.
• Ensure the maintenance and proper functioning of the BCQC laboratory equipment.

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Act as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Change Control and Risk Management within the EUCAN region....

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Complaint Management and Recall within the EUCAN region.
• Lead the regional standardization and harmonization of Complaint Management and Recall processes, ensuring alignment with GMP and GDP requirements.

• Serve as the Regional Business Process Owner for GMP/GDP Quality Assurance processes related to Deviation, CAPA, and OOx within the EUCAN region.
• Drive the standardization and harmonization of these processes at a regional level, ensuring alignment with both GMP and GDP requirements.

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.