Dedicated Operations Manager and effective leader who excels at using proven methods and cutting-edge technology to successfully cut costs, streamline operations and increase productivity. Skilled Operations Manager talented at improving team performance through innovative management techniques. Offers thoughtful, comprehensive and constructive feedback to staff members to promote productivity and company loyalty.
EU cGMP, UKMHRA AND TGA APPROVED PLANT
Method development, Method transfer &Method validation of
Finished product, Raw Material
Day to day Planning and execution of Raw material analysis, finished
products, Stability sample analysis, packing material analysis and follow
up to ensure the timely completion
Coordination with inter related departments (Warehouse, Production
& AR&D) for planning and execution of analysis.
Trouble shooting in all instruments like HPLC,GC,AAS, FTIR,
AUTOTITRATOR, etc.,
Method development & validation of HPLC, AAS, & GC etc.,
instruments.
Preparation and Review of Spec, STP and ROA
Identifying the analytical requirement (Chemical, Column, Working
standard etc.) Purchase and its maintenance & etc.
CO ordination and to execute the method transfer with Companies
Like Zydus, Ajanta, Torrent, Unichem for Loan license products
Control and Monitoring the GLP activities in QC LAB
Providing SOP training to Juniors and New entrants as per GLP
practice.
Planning of AMC for all applicable laboratory equipment's
Ensure the yearly monthly Calibration Schedules.
Co-ordinate with QA for rising change control, Incidents, Deviations.
Review all day to day documents and maintained in online.
Updating SOP, specifications, STP and GAM during Pharmacopeia
Updates
for AMT Transfer with AR&D, Market complaint sample analysis with QA
dept.
OOS investigation with QA dept.
Generation & Released of analytical reports through SAP