Key Objectives and Responsibilities
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Oversee the transfer and introduction of new or modified manufacturing processes into production
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Ensure that all aspects of the process, including equipment, raw materials, and procedures, are effectively translated into the production environment
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Prepare and review technology transfer documentation, including validation protocols, reports, and batch records
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Maintain documentation to ensure traceability and compliance with regulatory requirements
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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
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Analyse validation data and prepare reports to support the validation process
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Identify and resolve issues that arise during the transfer or scale-up of manufacturing processes
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Work with manufacturing teams to optimize processes for efficiency, output, and product quality
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Ensure that all technology transfer activities comply with Good Manufacturing Practices (GMP), regulatory guidelines, and company policies
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Prepare necessary documentation for submission to regulatory authorities as required
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Track project timelines and milestones to ensure that transfer activities are completed on schedule
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Conduct risk assessments related to the transfer of processes or technologies to identify potential challenges or risks
Qualifications and Experience Required
Qualifications and Work experience
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Bachelor’s degree of Pharmacy
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2+ years’ experience within the Pharmaceutical Industry
Knowledge and Skills
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Proficiency in MS Office (Excel, PowerPoint presentations)
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High analytical mind, with exceptional problem-solving skills and attention to detail
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Ability to work independently and collaboratively in a team environment, and adherence to cGMP and Quality Management Systems
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A self-starter, creative, innovative, flexible and able to work well under pressure at work
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Excellent communication skills, both oral and written
