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Qualifications, Skills and Experience:

Oversee the transfer and introduction of new or modified manufacturing processes into production
Ensure that all aspects of the process, including equipment, raw materials, and procedures, are effectively translated into the production environment
Prepare and review technology transfer documentation, including validation protocols, reports, and batch records
Maintain documentation to ensure traceability and compliance with regulatory requirements
Act as a liaison between Quality Assurance (QA), Quality Control (QC), Production, Regulatory Affairs (RA) teams to ensure smooth communication and collaboration during the transfer process
Analyse validation data and prepare reports to support the validation process
Identify and resolve issues that arise during the transfer or scale-up of manufacturing processes
Work with manufacturing teams to optimize processes for efficiency, output, and product quality
Ensure that all technology transfer activities comply with Good Manufacturing Practices (GMP), regulatory guidelines, and company policies
Prepare necessary documentation for submission to regulatory authorities as required
Track project timelines and milestones to ensure that transfer activities are completed on schedule
Conduct risk assessments related to the transfer of processes or technologies to identify potential challenges or risks