Job Description:
1) Independently lead analytical development team of Formulation Research for international business-Regulated markets including EU/US & emerging markets & ROW.
2) Guide team & make sure that project timelines for Analytical method development/validation/stability & routine analysis/reverse engineering for new & existing formulation of all dosage forms including IR/MR solid oral dosage form,softgelation capsules, pellets & parentrals,etc are met.
3) Prepare & review analytical TTD including specification, MoA, required protocols & to make sure that seamless method of transfer/verification at QC
4) Cleaning method development & validation
5)Prepare & review documents for analytical method development/validation/stability
6) Daily lab work planning and work allotment
7) Review of IO/OQ/PQ, calibration & upkeep of analytical instruments
8) Review of analytical SOPs specification/methods of analysis & analytical reports
9)Make sure that cGMP/cGLP compliance
10)Support & resolve analytical pre & post filing/registration regulatory queries for respective market 11)Executive quality by design concept during new product development
12) Have adequate knowledge and experience of handling various analytical instruments like HPLC,UPLC,UV,GC,IR,FT-IR, AAS, PSD by MalvernPolarimeter, Potentiometer, KFTitrator, MS, LCMS,etc "ONLY JOB-SEEKERS ARE PREFERED FROM PHARMA COMPANY DOING INTERNATIONAL BUSINESS"
Desired Candidate ProfileEducation:UG -B.Sc - Any Specialization, B.Pharma - Pharmacy
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