- Formulation development of robust, stable and effective formulations for regulatory markets.
- Prepare/review product development reports/ manufacturing documents/ protocols and analyse results.
- Support technology transfer/scale-up/validation activities.
DUTIES & RESPONSIBILITES:
- QbD based Formulation development of various dosage forms, at contract manufacturing organisation / development lab, for new product development.
- Report on adherence to schedule and trial status on a weekly basis to line Manager.
- Prepare/review product development reports/summary reports and analyse results.
- Preparation and review of SOPs and formulation documents. Comply with GMP’s, SOP’s and all regulatory documentation.
- Review formulation and analytical documents as provided, including those provided by production/manufacturing, quality control, quality assurance, supply, regulatory affairs.
- Prepare/review manufacturing documentation for pilot / small production runs / scale-up operations / Validation batches / Commercial batches. Monitoring the validation batches / Scale-up at manufacturing sites.
- Support in the set-up and operation of pilot scale equipment and instrumentation in the R&D lab. Co-ordinating performance qualification, calibration and maintenance of Formulation equipment/instruments.
- Research and compile documentation for pre-formulation / formulation assessment to ensure regulatory requirements, for new products development and existing products.
- Work with procurement and finance team to select materials (excipients/Raw Materials/ API) for product development activities. Recommend ingredients / processes which will improve the product development / existing product quality.
- Support technology transfer and scale-up activities to manufacture products at CMO.
- Participate in investigations into product failure and Ensure involvement in all trouble-shooting activities.
- Compile/review Raw Material and Finished Product Specifications, In-process specification, stability protocol, in collaboration with Product Development Dept. and Quality Assurance/ Quality Control Dept.
- Initiate stability testing (accelerated/long term/intermediate and product specific) of new products and review/report results in collaboration with Product Development Dept. and Quality Assurance/ Quality Control Dept.
- Coordinate with Product Development, Regulatory Affairs, Operations, QC/QA and Supply Departments to ensure that projects are planned and executed in a timely manner.
- Adhere to Health & Safety Policies and Standard Operating Procedures.