Srikanth Majeti

Work History

Associate Manager

Biocon Biologics Limited

Bangalore

11.2020 - Current

Responsible to conduct Audit across CMO Sites to maintain Data Integrity.
Responsible to maintain Quality across CMO sites.
Responsible to maintain Stability data, APQR data.
Analytical Data Review and Quality Trend Management
Perform Adhoc Audits to ensure consistency in Quality and data integrity as per schedule.
Preparation of Audit report and data integrity report & compliance.
Responsible to conduct Monthly meetings with CMO Sites to Improve or Maintain Quality Products.
Ensure Quality Matrix and Monthly Reports.
Preparation/Review of SOPs and Investigation reports for CMO QA department.
Initiating CCRs and deviations in QMS track wise.

MANGER – LIMS

PAR Formulations Pvt Ltd

Navi Mumbai

12.2017 - 09.2020

Responsible to Metrology, Documentation (E-Documentation).
Responsible in Procurement of New Instrument/Equipment by discussing with Vendors as per company’s requirement.
Performing Qualification (URS, DQ, IQ, OQ and PQ) of New Instrument/Equipment as per USP guideline.
Responsible for Preparing Calibration Schedule and Instrument Master Schedule.
Preparation of Stability protocols and stability Summary reports through Scientek and LIMS Software.
Responsible to Initiate Incident, OOS, OOT and Primary Investigations from Lab side.  Initiating Change Controls through QMS (Track Wise).
Responsible for lab readiness for internal and External Audits.
Preparation of Audit response reports with CAPA.
Coordinating with all Cross-functional Departments for ANDA submission.
Responsible to prepare trainings through compliance wire software (LMS).
Allocation of the work for Team Leaders, review of assigned work and monitoring the teamwork by collecting daily status report.
Technically supporting to the team to ensure the assigned work to be complete within time line.
Imparting the trainings to team members as per requirement.
Conducting weekly team meeting to get the best output of team members by considering their suggestions and concerns.
Attending the global call conferences with HOD and maintaining the MOM to complete the work on time.
Preparation of status Report and power point presentation as required.
Maintaining Team member’s appraisal and PMS as per company procedure.
Preparation, Review and approval of functional SOPs through Master Control Software (End User Administrator)
Responsible to prepare CSV protocol and perform for Lab related software to compile Lab requirements.

Specialist II

Apotex Research and Development Pvt Ltd

Bangalore

04.2015 - 11.2017

Creation of LIMS template (with the support of existing template).
Monitoring and Implementation of LIMS built at R&D, QC and Commercial stability laboratories of various plants.
LIMS Training to end users and Peer review.
Troubleshooting in LIMS to support the business as per requirements
As per 21 CFR, Monitoring Electronic Signatures and reviewing audit trails in LIMS to support Audit preparation.
Mapping the SAP codes to LIMS.
Implementation of Reducing test in LIMS as required.
Perform Impact analysis for SAP and LIMS
Creating new CCRs in QMS for Material Master, TT & PFP code inclusion.
Identifying the change control based on the risk (critical, major and minor) associated with each change.
Maintain change control for preparation of specifications in QMS Track Wise for Active materials, Excipient, Primary printed and packing materials, Intermediate and semi-finished product, Finished product & test profile and to deliver the documents within stipulated time-lines as committed.
Periodic revisions of the specifications to comply with new editions of pharmacopoeia or other official compendia.
Tech Transfer and Compendia notifications to the business
Managing document revision history in QMS Track Wise. Mdoc Execution & implementation in QMS
Manage the Method of analysis, Validation protocols in Doc bridge - Content 7
Preparation of Standard Operating procedures, Specifications, Standard Test Procedures and relevant Record of Analysis.
Certified Training: Internally Trained and certified Lab Ware Administrator at Level – 1

Quality Control Executive

Strides Arco Lab

Banglore

09.2012 - 03.2015

Ensure the compliance of analytical reports with respect to established specification.
Carry out the Analysis of Stability of Drug Products like Tablets, Hard Gelatin Capsules & Soft Gelatin Capsules as per Protocol.
Proficiency in all instrument related software and implementation Chromatographic Controls.
Performing Assay, Related substances, Identification, Dissolution, Content of uniformity, Disintegration, Melting range, Moister Content, Loss on Drying, Standardization, Titration and Extractions.
Calibration & maintenance of analytical instruments followed by SOP’s. .
To ensure Proper Documentation like Raw data, Instruments logs of analysis carried out in compliance with cGMP through LIMS.
Having good knowledge on Lab Deviations, Change Controls, OOT and OOS.
Having Knowledge on Analytical Method Validation & Analytical Method Transfer.
Designing & Validation of Excel sheets for Calculation different Analytical tests like Assay, Related Substances, Dissolution, Content of uniformity, Calibration, method transfer & method validation etc.
Preparation of SOP’s, STP’s & COA’s etc

Quality Control Executive

Piramal Health Care

Zaheerabad

09.2011 - 08.2012

Wet Analysis: IR Analysis by using Perkin Elmer operated by Spectrum One.
SOR (Specific Optical Rotation) analysis using by Jasco and operated by Jasco 2000.
Preparation and checking of COA and giving clearance to dispatch.
Ensure the finished product/intermediates HPLC analysis is done as per SOP.
Ensure that every specification and method of analysis used of right product/material code.
Optimization of formula, Process optimization trials, Feasibility and Validation
batches, Force degradation, Stability studies and packing development for smooth
execution at Scale up.
Involved in preparation and revision of SOP & maintenance and calibration of
equipment and conducted training programmes.
Cleaning validation and process validation.
Implementation and ensure the effectiveness of corrective and preventive action Processes and product performance monitoring.
Preparation of SPECIFICATION, TEST METHODS for APIs, labeling materials.
Co-ordination with logistics and production planning to ensure the dispatches as per the schedule.
Monitoring the calibration for the critical instrument and reviewing the supporting documents.

Quality Control Officer

Neuland Laboratories Ltd

Hyderabad

11.2008 - 09.2011

Validation Team Member.
Instrument Calibration (Analytical Weigh Balance, pH meter, KF, UV Spectrophotometer)
Analyzing stability studies & documentation.
Reaction monitoring and method transfer for CRO projects.
Analyzing In process, Intermediate and Finished Samples.

Senior Analytical Chemist

Kopalle Pharmachemicals Pvt Ltd

Hyderabad

Jul2005 - Oct2008

Regular analysis like HPLC, GC, UV, Dissolution of Pellets, Water Content in Pharmaceutical products.
Preparing Calculation Excel Sheets to report Assay, Related Substances.
Perform wet analysis like LOD, Solubility.

Summary

Overview

Work History

Associate Manager

MANGER – LIMS

Specialist II

Quality Control Executive

Quality Control Executive

Quality Control Officer

Senior Analytical Chemist

Education

Master of Science - Chemistry

Bachelor of Science - Mathematics, Physics, Chemistry

Intermediate -

S.S.C -

Skills

Languages

Timeline

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