JOB DETAILS:

Reports to: Quality Assurance Manager

 Key Objectives and Responsibilities

• • 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

Qualifications and Experience Required

Qualifications and Work experience

• Bachelor’s degree of Pharmacy
• 2+ years’ experience within the Pharmaceutical Industry

Knowledge and Skills

• Proficiency in MS Office (Excel, PowerPoint presentations)
• High analytical mind, with exceptional problem-solving skills and attention to detail
• Ability to work independently and collaboratively in a team environment, and adherence to cGMP and Quality Management Systems
• A self-starter, creative, innovative, flexible and able to work well under pressure at work
• Excellent communication skills, both oral and written