Farbe Firma

Ankleshwar, Gujarat

Responsible for ensuring that all regulatory requirements for the manufacture, testing, and approval of injectable pharmaceutical products are met. This includes preparing and submitting regulatory filings to the relevant authorities, maintaining compliance with applicable laws and guidelines, and ensuring that the injectable products are developed and marketed in accordance with regulatory standards.

- Set up and operate lyophilization machines, which include controlling key parameters like temperature, pressure, and drying times.-Oversee the entire freeze-drying cycle, from the freezing stage to the drying process, ensuring it aligns with predetermined specifications.- Continuously monitor the products during the freeze-drying process, checking for issues such as uneven drying, product collapse, or any other abnormalities.- Conduct regular inspections and sampling to verify the quality of the final freeze-dried product, ensuring it meets the required standards for moisture content and stability.- Record all relevant data on batch logs to ensure traceability and for compliance with regulations.- Identify and address any equipment malfunctions, such as temperature deviations or pressure irregularities, which could affect product quality.- Perform routine maintenance tasks like cleaning, calibrating, and troubleshooting the lyophilizers, ensuring the equipment remains in optimal working condition.- Work with the maintenance team to resolve any more complex equipment issues.