SANDEEP SAMBHAJI MALI
Pharmaceutical
Madgaon,GA
Summary
Address: Nilaya Homes, Near Don Bosco College Flat No. S2, Murida Fatorda, Goa, 403 602 Total Professional Experience: 18 Years _____________________________________________________________________________________________________ Objective: To deliver the best services with great efficiency. Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Overview
19
19
years of professional experience
Work History
Hardness Tester, Disintegration Tester
Assistant Manager
Micro Labs Limited
, Goa
11.2022 - Current
- Responsible for review and approval of Analytical method validation protocols and reports
- Supervising and conducting laboratory investigations for laboratory incident, OOS and OOT results
- Responsible for GLP Audits, Data integrity and Lab compliance
- Responsible for release of cleaning verification reports, online support to the production team
- Coordinating with members of Manufacturing, R & D and formulation to provide the analytical support
- Supervising QC analysts and shift leads, distributing workload and monitoring progress
- Ensure testing is performed accurately and in compliance manner with cGMP procedures, SOPs and other approved test methods
- Responsible for timely execution of method transfer and method validation activity
- Effectively planning of review and approval of test reports for FP, IP and CV
- Responsible for review of SOPs, STPs and Specifications
- Involved in planning, review and work allocation for routine CV
Officer
Cipla Limited
Pune
05.2006 - 01.2010
- Performed Analysis for Analytical Method Validation, Analytical Method Transfer on Tablets & Capsules by HPLC, UV-Spectrophotometer for tests like Assay, Related substances, Dissolution for finished products
- Preparation Protocol for Analytical Method Validation, Analytical Method Transfer for drug product.
Senior Executive
Lupin Limited
, Goa
01.2010 - 11.2022
- Review and approval of finished product, in process COA, stability, cleaning verification report
- Responsible for preparation of protocol and report for analytical method transfer, method validations, planning and execution of the validation study
- To ensure compliance of the analytical raw data and verification of electronic records
- Review and approval for laboratory investigation report (LIR), Out of Specification, Out of Trend, Atypical results in chromatography with proper investigation
- Preparation and review of new master sequence and method for HPLC/UV in chromeleon software
- Planning of routine analysis for FP, IP and AMT samples
- Review of new Standard Testing procedure, Specification, Analytical Work Record and other Master documents
- Online monitoring/Supervision/support to the analyst in routine analysis
- Review and Approval for laboratory Incident / deviation / CAPA in Quality Management System (QMS) software
- Review and approve Chromatographic data, Test Data Sheet, new STP and specification
- Responsible to conduct training for any change in SOP/STP/checklist using e-LMS software
- To ensure Qualification, Calibration and Preventive maintenance of instruments/ equipment is performed as per the schedule and review relevant documents
- Planning for review and release In-process, finished products, Stability Studies, Hold time reports
- Responsible for ensure/monitor the compliance in QC laboratory with respect to online documentation, CAPA effectiveness and GLP
- Familiar with software’s like SAP, e-LMS (Learning Management System), e-DMS (Document Management System), Chromeleon 6.8 (for HPLC analysis), Tiamo (For Water analysis), Lab solution (UV analysis), QAMS (Quality Assurance Management System)
- Instruments Handled:
- HPLC (Dionex, Agilent, Shimadzu)
- Dissolution Test Apparatus (Electrolab, Labindia)
- UV visible spectrophotometer (Shimadzu)
- Karl fisher (Metrohm)
- IR Spectrophotometer (Shimadzu)
Education
M. Tech - Pharmaceutical Operations and Management
BITs
June 2018
M.Sc. - Analytical Chemistry
Bharati Vidyapeeth University
April 2006
B.Sc. - Chemistry
Shivaji University
April 2004
Skills
- Team leadership
- Problem-solving
- Team motivation
Timeline
Assistant Manager
Micro Labs Limited
11.2022 - Current
Senior Executive
Lupin Limited
01.2010 - 11.2022
Officer
Cipla Limited
05.2006 - 01.2010
Hardness Tester, Disintegration Tester
M. Tech - Pharmaceutical Operations and Management
BITs
M.Sc. - Analytical Chemistry
Bharati Vidyapeeth University
B.Sc. - Chemistry
Shivaji University
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