Pavan Raghunath Jagdale
Deputy Manager in QA Department
Phaltan
Summary
To obtain meaningful and challenging position that enable me to achieve objectives of the organization and utilize my potential to the maximum for the benefit of the organization and my field.
Overview
3
3
Languages
13
13
years of professional experience
Work History
Deputy Manager
Cipla
05.2020 - Current
- Development and execution of validation document such as Gap Assessment, system requirement specifications, GxP assessment, 21 CFR Part 11 Assessment, Risk Assessment, Impact Analysis, Installation Qualification, Operational Qualification, Performance Qualification, Periodic Review.
- Checking the Functions like Audit trail, print report, Alarms and Data Integrity based on 21CFR part11, GAMP5 and cGMP Guidelines.
- System Security implementation and Data Backup Assessment Checklist execution.
- To perform qualification of Equipment’s, systems, areas, etc. and validation activities according to the validation protocol, report for the validation activities.
- Conduct risk assessment and determine validation or qualification needs based on gap analysis.
- Execution of the different software (Incrency software, E-log, Icon-Elog, Leucine, ECMRS, MES, SOP Viewer, EDLMS) at unit level.
- Experience in Developing and reviewing User Requirement Specifications URS, Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents.
- Hand in experience in validation of GAMP 5 system. Software design specifications, Functional Specification, Configuration Specification preparation.
- Internal audit review of project activities which involves evaluating documentation, implementation and impact of modifications made to the project plans, processes and deliverables which ensures adherence to standards, mitigates risks and maintains project integrity and compliance with organizational and regulatory requirements.
- Equipment qualification, Temperature Distribution Study of area.
- Conduct unit operation and review of change controls and Co-ordination with cross functional department related to system, facility, product, equipment, instrument, document change controls and study of impact related to changes through Cipdox/ TrackWise system based on the roles and rights provided in the system.
- Conduct unit operation and review for continuous improvement in updating of existing approved current SOP’s as per recent revisions in cGMP.
- Ensure investigation of process and procedure deviations are appropriately performed and documented. Taking appropriate corrective and preventive action based on the results of investigation which are identified and implemented.
- Handling of Impact assessment of change as mentioned in record handling form.
- Evaluate and investigate complaints and Recalls related to product quality received from any source.
Executive
Microlab Pvt Ltd
04.2018 - 05.2020
- Manpower Handling, work and tasks allocations to persons.
- Performing line clearance as per SOP in the process area and completion of appropriate documentation.
- Blend uniformity sampling for commercial and validation batches.
- Sampling of in-process and finished goods which include process validation/evaluation and commercial batches.
- Performing stratified sampling at manufacturing stages.
- Swab and rinse sampling for cleaning validation and chemical analysis.
- Performing in-process checks during all manufacturing steps.
- Sampling of hold time study and documentation.
- Perform AQL checks of tablets, capsule in case of any discrepancy.
- Calibration of IPQA instrument.
- To coordinate and collect the information for management review as a ‘Quality Management review coordinator’ and preparation of Quality management review report.
- Review of validation protocols and investigation reports.
- BFG Release.
- Review of BMR, BPR and verification of compliance.
- To perform activities in software like SAP, Cipdox, Tantrasoft, E-log, Production status display, Etrack, learning management system, SOP viewer and format issuance software etc. based on the roles provided in the system.
- Time synchronization study of IPQA instruments.
Sr. Quality Specialist
Watson Pharma, Pvt Ltd
05.2015 - 04.2018
Apprentice Trainee
Emcure Pharmaceutical Ltd
04.2013 - 03.2014
Education
Master’s in business administration - undefined
Symbiosis school for online and digital learning (SSODL)
06-2026
M. Pharm - Pharmaceutics
Shivaji University
Kolhapur01-2013
B. Pharm - undefined
Shivaji University
Kolhapur01-2011
Skills
MES (PAS-X)
SOP Viewer
SCADA
Incrency
Tantra
E-log
Leadership
Positive attitude
Self-motivated
Independent worker
Team worker
Interpersonal skills
Committed
Result oriented
Hard working
Zeal to learn new technologies
Ability to follow up on multiple tasks and projects
Current Status
Deputy Manager in QA Department, Cipla Goa.
Audit Faced
- USFDA
- MHRA
- WHO
- Goa FDA
- Zimbabwe
- Malawi
Personal Information
- Date of Birth: 13 Jun 1990
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Disclaimer
I, undersigned, certify that all the information provided by me is true to the best of my knowledge and beliefs.
Timeline
Deputy Manager
Cipla
05.2020 - Current
Executive
Microlab Pvt Ltd
04.2018 - 05.2020
Sr. Quality Specialist
Watson Pharma, Pvt Ltd
05.2015 - 04.2018
Apprentice Trainee
Emcure Pharmaceutical Ltd
04.2013 - 03.2014
B. Pharm - undefined
Shivaji University
M. Pharm - Pharmaceutics
Shivaji University
Master’s in business administration - undefined
Symbiosis school for online and digital learning (SSODL)