QAMS
M.A.N.V. Santhosh Kumar
M.Pharmacy
Bengaluru,India
Summary
Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem solving acumen. Assist superiors with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands
Overview
11
11
years of professional experience
7
7
years of post-secondary education
1
1
Certification
3
3
Languages
Work History
Sr. Executive
M/s Micro Lab Limited
Bangalore, Karanataka
07.2017 - Current
- Performed preparation and review of process validation protocols and reports.
- Associated with execution and compilation of process validation data and provided validation recommendations based upon the outcome of validation studies.
- Performed hold time studies and established hold time periods as an outcome of the studies.
- Prepared cleaning validation matrix, cleaning validation protocols and reports.
- Ensured appropriate training of personnel for proper execution of process, cleaning validation and hold time studies.
- · Compiled monthly status of validation studies for quality review meeting.
- Initiated and reviewed change controls, deviations associated with process validation process.
- Handling of QMS activities like Risk Assessment
- Assist QA Head and Quality Head during audits and Maintain QMS at plant.
- Handling of QMS related documents (Change control, Deviation, CAPA and incident etc.)
- Understand & supports to QA head in Risk Management, CAPA, Failure investigation and its reports.
- To ensure self-inspections and quality audits are carried out as per schedule and ensure compliance.
- Handling of Market complaint and quality related complaints.
- Review the Vendor questioners and maintain the vendor audits documents.
Executive
M/s Adcock Ingram limited
Bangalore, Karnataka
08.2015 - 06.2017
- Prepared tracking sheet of market complaints.
- Performed root cause analysis by conducting brain storming sessions and utilizing investigation tools like fault tree analysis, fish bone diagram, 5 why analysis.
- Initiated appropriate corrective and preventive action as an outcome of investigation and CAPA tracking.
- Associated with preparation of market complaint trend.
- Summarized annual summary report of received market complaints.
- Prepared annual product review reports.
- Associated with execution of activities of documentation cell like issuance, retrieval and archival of documents.
- Tracked and maintained control samples.
Supervisor
M/s Divis Laboratories Limited
Vishakhapatnam, Andhra Pradesh
12.2013 - 06.2015
- Giving training to personnel and evaluation of its effectiveness.(NICHLON)
- Handling of Training programmers as a training coordinator, Preparation of Master calendar and management of training records.
- Periodic review the training file and training calendars to compliance training system at plant.
- Handling of organogram & Job responsibility to concern
- Verification of dispatch activities
- Monitoring of Production activities on line.
- Routine Plant visit to ensure the cGMP Compliance.
- Verification of COA,s.
Education
Master of Pharmacy - Pharmaceutical Sciences
Lydia College of Pharmacy, Andhra University
Ravulapalam 06.2011 - 12.2013
Bachelor of Science - B.Pharmacy
Lydia College of Pharmacy, Andhra University
Ravulapalam 07.2008 - 03.2011
Diploma - D.Pharmacy
Koringa College of Pharmacy
Koringa 05.2006 - 03.2008
Skills
Validation & qualification Quality Management System Software skill in Trackwise, LIMS, SAP, Caliber QAMS, CLEEN Staff supervision Training
undefinedSoftware
LIMS
DMS
CLEAN
Certification
CERTIFIED LEAN SIX SIGMA BLACK BELT
Audits Faced
- US-FDA
- MCC
- MHRA
- TGA,WHO GMP Audit
- Other costumer Audits
Declaration:
I hereby declare that the information given above is true to the best of my knowledge.
M.A.N.V.S.Kumar
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
CERTIFIED LEAN SIX SIGMA BLACK BELT
09-2020
Sr. Executive
M/s Micro Lab Limited
07.2017 - Current
Executive
M/s Adcock Ingram limited
08.2015 - 06.2017
Supervisor
M/s Divis Laboratories Limited
12.2013 - 06.2015
Master of Pharmacy - Pharmaceutical Sciences
Lydia College of Pharmacy, Andhra University
06.2011 - 12.2013
Bachelor of Science - B.Pharmacy
Lydia College of Pharmacy, Andhra University
07.2008 - 03.2011
Diploma - D.Pharmacy
Koringa College of Pharmacy
05.2006 - 03.2008
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