Quality Excellence- Trouble shooting & Root Cause Analysis-
Interact with CFTs (Production, QC, QA,RA ) post the briefing of failures/deviations in process/product to further understand critical process, analytical and quality attributes; apply latest quality and statistical tools; perform systematic and scientific principles based investigation; perform experimentation and trials; collate and investigate experimental data; seek R&D and expert advice support as needed TO IDENTIFY THE ROOT CAUSE; check the reliability of proposed corrective actions either through experimentation or actual batch
Gather all the pertinint learning during root cause analysis, diagnosis , trouble shooting, implementation from quality and manufacturing excellence perspective in form of a report.
Conducting feasiblity trials on lab scale/ commercial equipment as per the requirement or plan; to study the outcome and submit reports; interact with equipment suppliersas necessaray IN ORDER TO execute the manufacturing improvement plans as per the identified issue in coordination of Production Team .
Execute the Exhibit batch , Pilot batch as per the scheduled timelines .
Execute the Site transfer batches as an when required as per the scheduled timelines .
Ensure the batch execution documents like BMR,BPR , Hold TIme Protocol ,Stability Protocol ,PVP ,sampling protocol are in place before the batch manufacturing .
NEW PRODUCT EVALUATION
Preapare the relevant manufacturing check lists and guidelines by refering to standarad unit opreration documentation and intetracting with operating personnel IN ORDER TO support manufacturablity evaluations of new products .
Ensure the relavent equipment , Accessories and tools are available before execution of batch .
M. Pharma with year 7-8 years of experience in Topical product like Cream ,Ointment ,Solution ,Lotion Gel.
Good understanding of investigational tools and root cause analysis; exposure to application of QbD, PAT and DoE; sound basics of formulation science, unit operations, scale up technologies, analytical methods and trouble shooting processes, working knowledge of Topical Drug Product formulation manufacturing .