Senior R&D Expert

Job Description

• Supervising the pre-formulation and formulation of new products, control and approval of the relevant documents.
• Supervising the preparation, control, and approval of validation documents for analytical methods.
• Supervising the preparation and approval of manufacturing methods for new formulations, determining critical points and control strategies.
• Supervising and approval of product scale-up reports.
• Monitoring the implementation of stability studies of new formulations, control, and approval of relevant reports.
• Monitoring the implementation of in-vitro studies of new formulations, control, and approval of relevant reports.
• Planning and monitoring the implementation of the product formulation modification process with the quality risk management approach.
• Supervising how personnel work with laboratory equipment and how they complete relevant documents such as equipment logbooks.
• Supervising the preparation, implementation, and review of all research and development SOPs.
• Determining the specification of starting materials and packaging materials required for new formulations.
• Identifying the required training of personnel and taking action to hold training courses based on defined internal procedures.
• Implementing elements of a quality management system such as deviation management and change management based on defined internal procedures.