Direct assistance to the Validation Team in process validation, cleaning and other qualification or validation, in which laboratory testing support is required.
To participate in the troubleshooting laboratory equipment failure and provide proposals for improvements.
To work towards achieving the R&D department KPI.
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Review interpreted analytical results, & grounding decision-based activities for product development with minimum Supervision from upper management.
Review trial batches of formulation development of tablets, capsules & other solid oral dosage form for global filings following QbD approach.
Responsible for identifying and addressing the technical trouble shooting for different stages of product transfer and product life cycle management.
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Conduct product trials, production trials and sensory evaluations; prepare samples for management approval and work closely with Production on successful implementation.
Prepare and maintain standardised recipes, product specifications, preparation methods, process instructions and R&D records.
Identify and troubleshoot issues related to recipes, ingredients, product quality and production processes, and recommend appropriate improvements.
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Prepare advanced samples, materials, equipment and other required tools for laboratory tests or development.
Perform comprehensive technical tests, analyse based on formulas and project requirements; tasks that require technical judgement.
Review and/or complete appropriate forms and documentation regarding research and development processes, tasks, results and conclusions. Draw conclusions and receive direction when required.
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Design and build testing jigs, fixtures, and validation setups to physically prove out new designs
Prepare and maintain detailed engineering, fabrication, and assembly drawings, along with technical documentation (installation guides, load rating datasheets, product specs)
Drive continuous improvement of existing products for manufacturability, performance, and quality
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