Scale-up & Technology Transfer: Partner with Analytical R&D, Production, and QA to run scale-up trials, manage pilot bioequivalence (BE) batches, and transfer technology to full-scale manufacturing.
Stability & Data Evaluation: Design stability protocols, monitor product performance across climatic zones, and troubleshoot out-of-specification or unstable trials.
Documentation & Compliance: Author and review technical documentation, including Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Records (MFR), and Common Technical Document (CTD) regulatory dossiers....
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...
Liaise with sub-contractors and house owners for scheduling of product measurement and installation services and update status accordingly from time to time.
Prepare all relevant documents pertaining to product measurement and installation services' request and promptly update all such information into system.
Ensure customers request, enquiry, feedback and complaints are logged and resolved on time....
To assist in analytical development and responsible in testing of samples for the related BI projects.
Execute formulation trials for product quality improvement and alternative / new materials evaluation, reviewing of trial results and update project progress status in a timely manner.
Responsible for technical document preparations required by RA, QA and other relevant departments; to ensure record traceability for the improvement projects’ experiment / test data....
Scale-up & Technology Transfer: Partner with Analytical R&D, Production, and QA to run scale-up trials, manage pilot bioequivalence (BE) batches, and transfer technology to full-scale manufacturing.
Stability & Data Evaluation: Design stability protocols, monitor product performance across climatic zones, and troubleshoot out-of-specification or unstable trials.
Documentation & Compliance: Author and review technical documentation, including Product Development Reports (PDR), Batch Manufacturing Records (BMR), Master Formula Records (MFR), and Common Technical Document (CTD) regulatory dossiers....