Sankar Sasmal
CQAIT, Automation, Audit support for 21CFR compliance for Eudralex, MHRA, UFDA
Mumbai,Maharashtra
Summary
Task driven professional with 15 years of experience in Quality in pharmaceutical Industries. Equipped with a record of consistently providing technical needs of companies through ingenious efforts. Proficient to understand user requirements, testing scripts, troubleshoot simple, complex issues and implement user requirement in consults with labware and developer as well based on management requirements.
Overview
15
15
years of professional experience
1
1
LABWare LIMS Administration 1 pharma template 7.0
1
1
Thermo scientific certified for chromeleon 7
Work history
QA IT, Compliance, CSV support and Audit
Cipla Ltd
Mumbai, Maharashtra
07.2012 - Current
- Corporate Quality IT with ampules of opportunity to work in different modules of LIMS (Laboratory Information Management system) i.e. Lot management, laboratory standard, instrument management, stability module, ad-hoc management, non conformances management, Instrument log management.
- Performing IQ, OQ, PQ for the category 3 and 4 Software as part of CSV activities.
- Coordination with cross functional teams and ensure availability of required support for development and implementation of LIMS across all sites.
- Followed up on corrective action requirements to verify resolution.
- Tracked quality metrics and implemented strategies to address underperforming areas.
- Inspected and documented incoming materials to address quality issues.
- Worked with internal teams to evaluate and implement quality initiatives.
- Gathered and reviewed current data to determine areas in need of improvement.
- Maintained compliance with regulatory requirements and company policies.
- Investigated customer complaints to address areas of improvement and eliminate non-conformances.
- Drafted reports detailing audit findings and corrective actions.
- Determined correct procedures for inspection and review to standardised audit processes.
- Reviewed project requirements to uncover challenges and recommend resolutions.
- Led internal audits to uncover vulnerabilities and quality issues.
- Trained and mentored direct reports within Quality Assurance department.
- Evaluated established processes to determine root cause of non-conformance.
- Review, approve of Generic analysis, OQ scripts
- Independely implementation of modules throughout sites instrument management, laboratort standards, chemical management, instrument interface with LIMS
- To modify simple parsing scripts, test script preparation for different instrument.
- Provide adequate training to 33 Laboratory in India and it's sister concern as well In South Africa.
- Establish discussion with vendor Europe and India for fast result of new enhancement.
- Administrative the full life cycle of LIMS.
- 100 support and guidance provided to user for their queries.
- Compliance to the computer system validation requirements for the LIMS related functionalities and responsible for creation, execution of CSV deliveries.
- Diagnosed and troubleshoot different surprises user got on day to day activities during handling of LIMS on production environment.
- Knowledge on HPLC, GC, semi micro balance, hybrid pH, conductivity meter and it's calibration, maintenance., looking after analysis, calibration of all Quality control instruments including analysis loading in HPLC and GC.
- Completed non-conformance reports with precision and accuracy, reducing errors by 20%.
- Back up validation.
Quality Control Officer
Micro Labs Ltd
Bangalore
09.2009 - 07.2012
R &D Analyst
Meghmani Organic limited
Ankleshwar, Gujarat
01.2008 - 01.2009
- Working on developing cupper thalo cyanin for FT and TT
- Worked flexible hours across night, weekend and holiday shifts.
- Proven ability to learn quickly and adapt to new situations.
- Paid attention to detail while completing assignments.
Education
Master of Business Administration - Business Administration in operations management and Health care management
IICT Business School
2015
Master of Science - M. Phil in Bioinformatics
Nagaland University
NagalandMaster of Science - Bioinformatics
Gandhi Institute of Biological Sciences
GunupurBachelor of Science - PCM Major Biotechnology
Kalinga Maha Vidyalaya
G.udayagiriSkills
- TECHNICAL SKILLS
- Relational database design
- MS office, Linux, Windows, Mac
- Oracle 9i DBA and HTML
- 6 sigma
Accomplishments
- LIMS (Laboratory Information Management system) strategy
- Idea bank of quality control for reducing non productivity activities for mckensie
- Laboratory standards lifecycle in LIMS
- Instrument interface with LIMS moxa based
- Laboratory chemicals management in LIMS
- LIMSchrome connectivity
Additional Information
- SARS is an air borne disease it spreads quickly then other viral diseases. It becomes more dangers then HIV because it spreading faster rate, it takes 2 to 10 days. SARS spreads indiscriminately and patients have varied more widely in age. But for unknown reasons, SARS has largely spread in children. The most important agent of SARS is Coronavirus.Taking target protein from Coronavirus strain and finding the most suitable ligands for it. I try to find a new bioactive compounds or drug using HEX 4.5. RELEVANT COURSEWORK Molecular Biology: Advanced Methods in Biotechnology I and II (DNA isolation from bacteria and Yeast, Yeast two hybrid system, PCR reaction, restriction digestion, SDS-PAGE, Blotting techniques, sterilization techniques, 2D gel electrophoresis) Theoretical Concepts: Applied Biotechnology, Bioethics, Patho-physiology Eukaryotic gene expression laboratory: RNA based research techniques. Applied statistical methods: Statistical methods applied to Biological experiments. Oracle database administrative and 9i SCIENECE SYPOSIUM Knowledge Nexus of Chemical Engineering and Bio-Technology A winning combination, Successful commercialization of Bio-pharmaceutical products: In GIET Gunupur. International Symposium on computational Biology and Bio-Informatics (ISBB 06)
Languages
English
Upper intermediate
Hindi
Intermediate
Bengali
Beginner
Telugu
Beginner
Nepali
Beginner
Certification
- CQA - Certified Quality Analyst
- Labware LIMS Administration 1 pharma template 7.0
- Thermo scientific certified for chromeleon 7
Interests
Reading books
Cooking
Work availability
Monday
Tuesday
Wednesday
Thursday
Friday
Saturday
Sunday
morning
afternoon
evening
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Software
Labware LIMS
Cipdox
Matrix 42
Chromeleon 71
Leucine 30
Quote
Your vision will become clear only when you can look into your own heart. Who looks outside, dreams; who looks inside, awakens.
Carl Jung
Timeline
QA IT, Compliance, CSV support and Audit
Cipla Ltd
07.2012 - Current
Quality Control Officer
Micro Labs Ltd
09.2009 - 07.2012
R &D Analyst
Meghmani Organic limited
01.2008 - 01.2009
Master of Business Administration - Business Administration in operations management and Health care management
IICT Business School
Master of Science - M. Phil in Bioinformatics
Nagaland University
Master of Science - Bioinformatics
Gandhi Institute of Biological Sciences
Bachelor of Science - PCM Major Biotechnology
Kalinga Maha Vidyalaya
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