Post graduate in Organic Chemistry with 11+ years of experience in Formulation Quality Control, Quality R&D Lab Operations, Documentation, Data Review complying to cGMP practices in accordance with company policies, procedures, federal regulations and safety requirements.
Resourceful in ensuring compliance to quality and regulatory measures by maintaining appropriate documentation and records in accordance with USFDA, MHRA, TGA, Health Canada standards.
Effective communicator with strong analytical, problem solving and organizational skills.
Overview
11
11
years of professional experience
Work History
Sr. Executive
Apotex Research Private Limited
Bangalore
12.2016 - Current
Responsible in managing product release programs for Incoming Raw materials by Planning Analysis as per SCM targets.
Preparation of Exhibit reports for Raw material Reduced testing program.
Supervise chemists to check progress of analysis for release and ensure assigned tasks are performed on timely manner to sustain a consistent turn around time for release of materials and products.
Review of Analytical Documents for Data completeness to release on time product release.
Responsible for initiation and closure of Laboratory Investigations in QMS TrackWise/LIMS (OOS, OOT, Anomalous results and Lab events) by participating in root cause analysis using different tools like Fish Bone Analysis, 5-Why analysis and identifying the areas of obstruction / quality failures including risk assessments and brought to resolution by advising on system and process changes for qualitative improvement within stipulated timelines as committed.
Responsible for implementation of CAPA and action plans generated from the notifications.
Adapted to numerous changes in laboratory including implementation of 6S, QMS, POBOS etc.
Responsible for managing and conducting all training programs communicating with managers to identify training needs for various cross functional teams.
Proficient with Data interpretation, Instrument Troubleshooting of Analytical Instruments, Investigation complying with Regulatory agencies requirements.
·Preparation of Method verification, Feasibility and method transfer protocols and summary reports.
Review Audit Trails of Empower software and Standalone Instruments software’s as per schedule.
Responsible for implementation of kaizen at workplace.
Execution of Instrument qualification (IQ, OQ, PQ), Validation of Computerized System following 21 CFR Part 11, GAMP5 requirements as Quality Representative accompanying Validation specialist.
Executive
Orchid Chemicals & Pharmaceuticals Limited
Chennai
04.2016 - 12.2016
Analysis of Samples using chromatographic techniques.
Preparation of SOP’s, Methods and Worksheets.
Review of Analytical raw data worksheets.
Support to Analytical method transfer, method verification.
Preparation of Protocols and reports.
Jr. Officer
Hetero Labs Limited
Hyderabad
12.2012 - 04.2016
Sampling and Analysis of Raw materials.
Sampling and Analysis of water samples.
Calibration of Analytical instruments.
Working standard qualifications and Maintenance of standards.
Support for IP/FP and Stability analysis.
Education
Master of Science - Chemistry
Sri Sai College (OU)
Hyderabad
06-2011
Bachelor of Science - Chemistry
Thushara Degree College (KU)
Warangal
06-2008
Skills
Labware LIMS Version 5
Empower 3 Custom Field Application
Field Application QMS Trackwise
Validator Application
SAP
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
INSTRUMENTATION PROFICIENCY
HPLC (Shimadzu with Lab Solutions, Agilent, Waters with Empower 3.0 Software).
GC (Agilent7890A) with Empower 3.0 software.
IR (Shimadzu with IR Solutions and Bruker with OPUS Software).
UV (Shimadzu with UV Probe Software) Spectra analysis.
Autotitrator (Tiamo software)
Polarimeter (Autopol IV)
Analytical balance and pH meter
STRENGTHS
Teamwork: Successfully led a team of 9 technicians, optimizing workflow, which resulted in a 30% increase in productivity.
Detail Oriented: Successfully identified and resolved minor inconsistencies in laboratory outputs, aiding in maintaining peak operational efficiencies.