Kishor Kishanrao Nimbare

Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.

Proposal to perform water activity test instead of MLT test and successfully implemented in alembic pharmaceuticals

• UPDATION OF PHARMACOPOEIAL UPDATES.
• REVIEW OF RISK ASSESSMENT OF SOFTWARE.
• REVIEW OF IQ,OQ,OO OF SOFTWARE .
• APPROVAL OF SPECIFICATIONS, TDS, ATP IN D2 SOFTWARE
• APPROVAL OF CAIBRATION SCHEDULE, PM SCHEDULE, MONTHLY AUDIT SCHEDULE IN D-SCHEDULER SOFTWARE
• PREAPPROVAL AND POST APPROVAL OF QUALIFICATION,REQUALIFICATION PROTOCOLS
• REVIEW OF EM AND MLT REPORTS.
• REVIEW OF MONTHLY TRENDS OF WATER AND EM
• WEEKLY FOLLOW UP OF CALIBRATION, QUALIFICATION SCHEDULE
• MONTHLY AUDIT TRAILS OF QC INSTRUMENTS
• REVIEW AND PREPARATION MICROBIOLOGICAL SOPs
• REVIEW AND UPDATION PHARMACOPOEIAL EVALUATION CHANGES
• ACTIVELY INVOLVED IN PRAPAARATION OF VALIDATION PROTOCOLS OF MICROBIOLOGY SECTION
• ACTIVELY INVOLVED IN PHYSICAL INSPECTION OF CONTROL SAMPLES.
• ACTIVELY INVOLVED IN PRREPARATION OF IQ, OQ AND PQ OF QC INSTRUMENTS.
• PREPARATION AND REVIEW OF QA SOPs.
• APPROVAL OF STABILITY GRIDS.
• TRAINING TO NEW MICROBIOLOGIST.
• ACTIVELY INVOLVED IN TRACKING OF ANALYST QUALIFICATION MATRIX.
• REVIEW OF CHANGE CONTROLS OF QC DEPT.
• REVIEW OF OOS, OOT OF QC DEPT.
• ACTIVELY INVOLVED IN INVESTIGATION PREPARATION OF MICROBIOLOGY DEPT FOR OOS, DEVIATION, INCIDENTS
• PREPARED COMPLIANCE TO 483S FOR MICROBIOLOGY DEPT
• ACTIVELY INVOLVED IN INTERNAL AUDIT OF CFT DEPARTMENTS

• Completed MS-CIT with 74% marks.
• Completed typing with the Speed of 40 WPM In English and Marathi with the speed of 30 WPM