Responsibilities:
• Lead in Process Validation to ensure processes used are validated in compliance with cGMP and regulatory requirement;
• Lead team to conduct product analytical testing for Process Validation Sample and others.
• Create product SOPs according to reference
• Develop existing product development and review, improve to acceptable internal and external quality standard in line with global good manufacturing, laboratory and other appropriate practices.
• Lead the team upon assigned new projects
• Involve in quality issues in line with regulatory and compliance issues.
• Involve in product transfer project in areas of formulation, product trials and technology transfer;
• Performing equipment performance qualification if necessary.
• Conduct Generic and proprietary product and manufacturing process research, design, development and improvement;
• Performing finished product comparison dissolution profile and analytical Method validation if necessary.
• Train and groom existing team in the R&D department
• To carry out any other duties assigned by your immediate superio
