SWAPNA TANDLE
Analyst
Sangli
Summary
10+ years of experience in pharmaceuticals, biotech manufacturing industry with software development life cycle, 21CFR part-11 Q&V, change control Management system and QMS activities. Significant experience in reviewing of computer system validations CSV deliverables according to 21 CFR part 11 and FDA regulations for pharmaceutical industries. Excellent knowledge and experience in Good documentation practices. Demonstrated capability to quickly gain and detailed understanding of process in order to optimize efficiencies and improve quality.
Overview
9
9
years of professional experience
6
6
years of post-secondary education
4
4
Languages
Work History
Analyst (Assistant Manager)
Sanofi India Healthcare Limited
Hyderabad
10.2022 - Current
- Develop and update the standard operating procedures related to Qualification and Validation as per the regulatory requirements.
- Review and approval of Qualification and Validation (Q & V) life cycle documents related to facility, system, process and equipments.
- Preparation and Review of qualification and validation protocol as per regulatory requirement.
- Review and approval of URS, FS, FAT, SAT.
- Review of periodic review report, audit trails.
- Review and Approval of traceability matrix.
- Finalization and certification of IQ and OQ protocol.
- Actively involvement in audit compliances related to computer system validation.
- All time inspection readiness.
Senior Executive
Wytells (Aurobindo) pharma limited
Hyderabad
06.2020 - 10.2020
- In Quality Assurance
- Review and approval of Qualification and Validation activities as per Validation Master Plan.
- Investigation of environment monitoring excursion.
- SOP preparation and review to inline with current regulatory guideline compliance.
- APQR Preparation and review.
- Preparation and Review of computer system Validation Protocol (URS, DQ, IQ, OQ, PQ) inline with 21 CFR part 11 and EU Annex11.
- Review of Traceability Matrix to define the relationship between requirements, design specifications and test scripts
- Preparation and review of HLRA
- PLC & HMI , SCADA qualification
- Proficient in conducting 21 CFR Part 11 assessments on new and existing computerized systems.
- Author, execute, perform, and summarize CSV documents.
- Management Plans, Installation/Operational/Performance (IOP) Qualification
- Review and approval of Requirement of Traceability matrix (RTM)
- Extensive knowledge in writing templates for URS, FRS, FAT, SAT, UAT
- Validation of computerized system in accordance with GAMP5 and V-model.
- Skilled in developing a gap analysis matrix and conducting root cause analysis, deviation resolution (CAPA), and effectiveness checks for CSV
- Assessment, Validation Summary Report, Data Transfer, Integrity Testing Protocol and Change control
- Developers, users and testers throughout the entire software development lifecycle to identify and analyze requirements
- Verification of privilege’s and audit trails in all Applications.
- Handling of QMS activities ( Change control, deviation, CAPA review)
Senior Officer
Indoco Remedies Limited
Verna
08.2018 - 02.2020
- Handling of QMS activity (Change control, Deviation, CAPA)
- finalization of Environment monitoring locations with scientific rationale.
- Investigation of environment monitoring excursion.
- Installation and qualification of HMI
- Preparation of URS
- Preparation and review of risk assessment
- Preparation and review of qualification’s and validation Protocols for equipment’s and instruments
- Preparation and review of Standard operating procedures
- Execution of validation and Qualification activity with external vendor
- Co-ordination with team, knowledge sharing activities and participating in team building activities.
Senior Officer
Dales Remedies Pvt Ltd
Mumbai
11.2017 - 07.2018
- Preparation and review of SOPs
- Review of Change Control.
- Deviations targets and closure.
- Validation master plan review and preparation.
- Verification of privileges and audit trails in all applications
- Development of CSV protocol as per regulatory requirement.
QA Officer
Cipla -Medispray Pharma Limited
07.2012 - 10.2017
- Handling of Caliber LIMS
- Handling of QMS activity (Change control, Deviation, CAPA).
- APQR Preparation.
- Preparation of Qualification (IQ, OQ,PQ) Protocols
- Validation of Autoclave
- Qualification of Incubators
- Installation and qualification of colony counter.
- Investigation of Environment monitoring excursion.
- Sterility Test review.
- Bacterial Endotoxin Test review
- Media Preparation and Growth promotion test Review
- Review of microbial analysis report
Jr.Chemist
Cheryl Pharma Pvt Ltd
Mumbai
08.2011 - 07.2012
- Environment Monitoring.
- Water Sampling and Analysis.
- Media preparation and reporting.
- Growth promotion test execution and reporting.
Education
Bachelor of Science - Microbiology
Shivaji University
Islampur, Sangli 06.2006 - 06.2009
Master of Science - Microbiology
Shivaji University
Satara 08.2009 - 07.2011
MBA - Pharmaceuticals
NIBM
Online 08.2020 - 08.2021
Skills
Time Management
Additional Information
- Personal Information
Timeline
Analyst (Assistant Manager)
Sanofi India Healthcare Limited
10.2022 - Current
MBA - Pharmaceuticals
NIBM
08.2020 - 08.2021
Senior Executive
Wytells (Aurobindo) pharma limited
06.2020 - 10.2020
Senior Officer
Indoco Remedies Limited
08.2018 - 02.2020
Senior Officer
Dales Remedies Pvt Ltd
11.2017 - 07.2018
QA Officer
Cipla -Medispray Pharma Limited
07.2012 - 10.2017
Jr.Chemist
Cheryl Pharma Pvt Ltd
08.2011 - 07.2012
Master of Science - Microbiology
Shivaji University
08.2009 - 07.2011
Bachelor of Science - Microbiology
Shivaji University
06.2006 - 06.2009
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