lead&plan projects-pellets/mups,meet TPP, timelines,budget-FRD(FBC,RMG,Coating,Nano),interpret ARD results,delegate & monitor teams, Ensure compliance: MFR,scale-up,stability protocols,PDRs,SOPs,GMP,SHE Technical discussions-DQA, ARD, Marketing, Required Candidate profile FRD pellets/modified release, QbD,cGMPs, GLPs, expertise in process and formulation optimization,tech transfer&scale-up -FBC,RMG,coating,extrusion,nanotech, DIPO qualification, validation, spec review
develop/optimise pellets/mups - FRD(FBC,RMG,Coating,Nano),interpret ARD results,delegate & monitor teams, enforce GLP&GDPs, prep/review: MFR,scale-up,exhibit & stability protocols,PDRs, SOPs cross-function coordination, meet TPP, timelines,budget. Required Candidate profile FRD pellets/modified release, QbD,cGMPs, GLPs, expertise in process and formulation optimization,tech transfer&scale-up -FBC,RMG,coating,extrusion,nanotech, DIPO qualification, validation, spec review
Ensure/Verify—batch release, SOP compliance, GMP & documentation control Record & review—all production and Engineering & Maintenance activity & related QMS Conduct—Audits, gap analysis. Prepare—DMF, CTD, VMP, SMF, protocols Required Candidate profile QA lead—oral solids SOP/GMP & doc control QMS—deviations/CAPA/CC/complaints, root cause investigation APQR process/cleaning validation & CSV IQ/OQ/PQ & calibs stability & summaries auditing DMF/CTD
QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,
Responsible for management of IT infrastructure,network security & CSV in compliance with cGMP & 21CFR Part11 guidelines. Ensures continuous operation of servers,networks & GMP systems while maintaining data integrity,security & regulatory compliance
QC planning; GLP/QMS; chemist schedule/qualification Plan/review validation, calibration -AMC/CMC; audits; SOP/STP prep/training; COAs; stability loading/protocols prep Compile batch analysis data Indent materials Internal/External Mail coordination Required Candidate profile QC lead(GMP pharma—oral solids). GLP/QMS docu; ICH method & process validation HPLC/GC/UV, dissolution stability; OOS & CAPA-change control; monthly SOP/STP prep/review-mentoring, working std dev,
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