Shivaraj V
Anekal
Overview
11
11
years of professional experience
Work History
QC-Scientist
Cydmax(India) Pharma Pvt.Ltd
01.2023 - Current
- Preparation and review of Standard operating procedure (SOP)
- Preparation and review of specification and Method of analysis for new products (Raw material, Finished product, Shelf life and Packing material)
- Preparation and Review of Analytical method validation (AMV) protocols and reports
- Preparation and Review of Analytical method verification (AMV) protocols and reports
- Preparation of investigation and root cause identification report
- Handling of Lab incident and Out of specification hypothesis studies
- Lab incident and out of specification investigation, Impact assessment, Root cause identification, Evaluation and CAPA writing using investigation tools
- Analysis of finished products samples & stability samples
- Receipt of samples for stability study and allocation of stability protocol number
- Maintenance of reserve samples
- Adherence to good laboratory practice
- Preparation of stability protocol as per the scope of work agreed
- Inception of stability samples & pulling out the samples as per the stability protocol
- Data recording and reporting as per the stability protocol
- Maintenance of specifications & protocols in designated places & preparation of stability summary report post stability analysis
- Destruction of samples as per the protocol
- Coordination with external service engineer incase of instrument break down
- Technical liaison between cross functional teams like production, SCM, Warehouse and QA
- Handling QMS documents like Incidents, OOT, OOS and change controls Execution of Pharmacopeial Method verifications, Method feasibility
- Training Analysts on QMS, SOP, cGMP and to perform proper Laboratory procedures and Instrumentation and other wet analysis.
QC-Scientist
Anthem Bio-Sciences Pvt. Ltd
01.2020 - 01.2023
- Analysis of finished products samples & stability samples
- Receipt of samples for stability study and allocation of stability protocol number
- Maintenance of reserve samples
- Adherence to good laboratory practice
- Preparation of stability protocol as per the scope of work agreed
- Inception of stability samples & pulling out the samples as per the stability protocol
- Data recording and reporting as per the stability protocol
- Maintenance of specifications & protocols in designated places & preparation of stability summary report post stability analysis
- Destruction of samples as per the protocol
- Coordination with external service engineer incase of instrument break down
- Technical liaison between cross functional teams like production, SCM, Warehouse and QA
- Handling QMS documents like Incidents, OOT, OOS and change controls Execution of Pharmacopeial Method verifications, Method feasibility
- Training Analysts on QMS, SOP, cGMP and to perform proper Laboratory procedures and Instrumentation and other wet analysis.
Executive-QC
Sequent research Ltd
12.2016 - 03.2020
- Analysis of validation finished products samples & stability samples
- Analysis of samples for Assay, Dissolution, Blend Uniformity Operation and calibration of HPLC
- Operation and calibration of instruments like, IR, UV, Dissolution tester, Disintegration tester, Friabilator, Ph meter, Weighing balance Operation and calibration of XRD Documentation and internal audit experience
- Receiving of samples from external vendors Generation of Analytical reference numbers for samples through LIMS software
- Qualification / Characterization and maintenance of reference Standards
- Stability studies and stability management as per ICH guidelines
- Preparation of SOP, protocols and reports for standard qualification activity
- Review of protocols,analytical reports to in line with compliance
- Handling QMS documents like Incidents, OOT, OOS and change controls
- Handling of analytical instruments like HPLC, GC, Autotitrator, UV, Polarimeter and FT-IR
- Stability analytical activity and review of stability documents
- Planning, execution and leading of analyticalteam
- Maintenance of logbooks and adherence to good manufacturing practices
- Adhering to ALCOA+, GLPand cGMP
- Monitoring the Lab cleanliness and safety standards properly in the day-to-day work execution
- Training fellow Analysts on QMS, SOP, cGMP and to perform proper Laboratory procedures andInstrumentation and other wet analysis.
Senior Executive-QC
Geltec Pvt Ltd
06.2016 - 12.2016
- Handled finished product , Stability Sample analysis and documentation (Formulation)
- A good documentation work according to cGLP
- Notify any OOS/OOT result observed during analysis and investigation
- Packaging and labelling of stability samples and inception of stability samples in chambers
- Having knowledge on 5 different formulations like Tablets, Hard gelatin Capsules, Soft gelatin Capsules, Sachets/powders
- Key participant in planning activity w.r.t stability samples
- Co-ordination with cross functional team for risk assessments.
Executive-QC
Strides Arcolab Ltd
02.2014 - 03.2016
- Worked in in process, and finished product analysis and documentation
- Handling of LIMS software (LABWARE)
- Analysis of Validation in process samples (Particle Size Distribution, Tap density/Bulk Density, Angle of Repose and Moisture content) Documentation and internal audit experience
- Online verification of documents and ensuring that the analysis is done as per cGLP
- Notifying an OOS/OOT result during analysis.
Education
M.Sc (Biotechnology) - undefined
B.Sc (CZMB) - undefined
PUC (PCMB) - undefined
S.S.L.C - undefined
Skills
MS Office
MS Excel
Knowledge about SAP, ICH guidelines, USP, EP, JP, IP pharmacopeias
Carrierobjective
Seeking a responsible and challenging career in a dynamic environment and to involve myself in the growth process of the organization where I can learn new things and build on my experience every day.
Personal Information
- Father's Name: Venkatesh A
- Mother's Name: Usha R
- Date of Birth: 12/12/88
- Marital Status: Married
Keyrolesresponsibilities
- Preparation and review of Standard operating procedure (SOP).
- Preparation and review of specification and Method of analysis for new products (Raw material, Finished product, Shelf life and Packing material).
- Preparation and Review of Analytical method validation (AMV) protocols and reports.
- Preparation and Review of Analytical method verification (AMV) protocols and reports.
- Preparation of investigation and root cause identification report.
- Handling of Lab incident and Out of specification hypothesis studies.
- Lab incident and out of specification investigation, Impact assessment, Root cause identification, Evaluation and CAPA writing using investigation tools.
- Analysis of finished products samples & stability samples.
- Receipt of samples for stability study and allocation of stability protocol number.
- Maintenance of reserve samples.
- Adherence to good laboratory practice.
- Preparation of stability protocol as per the scope of work agreed.
- Inception of stability samples & pulling out the samples as per the stability protocol.
- Data recording and reporting as per the stability protocol.
- Maintenance of specifications & protocols in designated places & preparation of stability summary report post stability analysis.
- Destruction of samples as per the protocol.
- Coordination with external service engineer incase of instrument break down.
- Technical liaison between cross functional teams like production, SCM, Warehouse and QA.
- Handling QMS documents like Incidents, OOT, OOS and change controls
- Execution of Pharmacopeial Method verifications, Method feasibility.
- Training Analysts on QMS, SOP, cGMP and to perform proper Laboratory procedures and Instrumentation and other wet analysis.
Instrumentsoftwarehandled
- HPLC Shimadzu prominence-i series (Lab solutions 6.82 V)
- UV (Shimadzu-1800 series), Winaspect.
- Dissolution tester (Electrolab & lab India).
- Autotitrator (Metrohm).
- FTIR (Perkin Elmer, Agilent micro-PC, shimadzu).
- Disintegration Apparatus (Electrolab)& (Lab India).
- Rheo Meter (Brooke Field).
- Friabilator (Electrolab).
- Hardness Tester (Erweka).
- Ph (Eutech &metrohm).
- X-ray diffractometer. (PAnlytical)
Languages
Tamil
English
Telugu
Kannada
Disclaimer
I hereby declare that the above given information is true and correct to the best of my knowledge and belief.
Timeline
QC-Scientist
Cydmax(India) Pharma Pvt.Ltd
01.2023 - Current
QC-Scientist
Anthem Bio-Sciences Pvt. Ltd
01.2020 - 01.2023
Executive-QC
Sequent research Ltd
12.2016 - 03.2020
Senior Executive-QC
Geltec Pvt Ltd
06.2016 - 12.2016
Executive-QC
Strides Arcolab Ltd
02.2014 - 03.2016
M.Sc (Biotechnology) - undefined
B.Sc (CZMB) - undefined
PUC (PCMB) - undefined
S.S.L.C - undefined
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