Duties and Responsibilities
- Establish R&D procedures and work processes.
- Development of new and/or improved product formulation to meet pharmacopeia requirements.
- Development of suitable manufacturing process for the product formulation.
- Produces sample batch in lab scale and pilot scale.
- Responsible for effective technology transfer and upscaling to commercial scale batches.
- Participates in process validation for the R&D batches.
- Provides training to production personnel on improved formulation and manufacturing processes.
- Ensures suitable test method is developed and validated for the new/improved products.
- Trouble-shooting in the areas of formulation and process for routine production.
- Participation in the investigation of product complaints (if applicable).
- Monitors the progress of stability study for R&D samples.
- Establishment of technical information e.g. specifications of raw material, packaging materials, finished products.
- Provides documentation to support registration of products with regulatory authority.
- To ensure the quality of product is in accordance with the specification.
- To review and feedback if there is any improvement needed for the process of manufacturing.
- To ensure that products are produced, stored according to the appropriate documentation and monitor storage conditions for materials and product in order to obtain or maintain the required quality.
- To inspect, investigate and take samples in order to monitor factors which may affect product quality.
- To ensure all products, in process materials, production facilities and process are in accordance to codes of Good Manufacturing Practice (GMP) requirement through proper monitoring procedures, effective training program and up to date documentations.
- To monitor drugs manufacturing activities and ensure company is always in compliance with the latest PICS & GMP guideline.
- To ensure that company is always updated with the latest guideline required.
- Review and make recommendation for improvement in area of manufacturing processes, safety, environment, sanitation and hygiene.
- To approve the instruction relating to production operations and to ensure their strict implementation.
- To ensure the qualification and maintenance of his department, premises and equipment.
- To ensure that the appropriate validations are conducted timely and accordingly.
- To ensure all GMP quality related record are kept properly
Requirement
- Bachelor Degree/Master in Pharmacy/Pharmaceutical Sciences
- Minimum 2 - 5 years’ experience in pharmaceutical industry
- Minimum 2 years’ experience in drug development and formulation as well as manufacturing process/technologies
