Soham Shinde
Pharmaceutical Quality Assurance
Pune
Summary
Experienced Quality professional with a demonstrated history of working in the pharmaceuticals industry. Skilled in Quality Management System, Pharmaceutics, Corrective and Preventive Action (CAPA),Change Control Management (CC), Auditing, Computerized System Validation (CSV), Risk assessment ,Deviation management, Vendor management electronic Document management system (Documentation), electronic Quality management system (Trackwise), electronic Training management system (SABA, SAP Success factor) and Good Laboratory Practice.
Overview
6
6
years of professional experience
6
6
years of post-secondary education
Work History
Executive Officer (QMS)
Serum institute of India Pvt Ltd
Pune
09.2022 - Current
- Maintain an adherence to the Current Good Manufacturing Practices (cGMP)
- Review, Logging and tracking of Change Control, Deviation and CAPA
- Preparation and review of trends for change control
- Co-ordination with stakeholder for effectiveness verification of Change Control Corrective and preventive action (CAPA)
- Review Batch manufacturing record (BMR) and draft Master BMR & MFR
- Performed schedule inspection in all areas of manufacturing facility
- Review of Audit trail and electronic records of all GXP equipment and systems having audit trail generation
- To ensure all instruments calibration/Preventive maintenance status maintained as per predefined schedule
- To support team member during all costumer, safety, internal and regulatory audit
- To ensure basic norms of cGMP & safety are being followed
- To ensure proper cleanliness & maintenance of department, premises and equipment
- To ensure online, timely, legible and correct entries of all operations
- Review of filled batch manufacturing record (BMR)
- Participation in investigation of any non-conformance in manufacturing
- Assembling and review all documentation related to processing of each batch of the product before submission to QA
- Responsible to maintain all the necessary control on starting material, intermediate product and other in process control
- Online review of document like sequential log book record, temperature, pressure, % humidity record & E-log on monthly basis
- Any other assignment allocated by Head unit Quality assurance.
Senior Officer
Glenmark Pharmaceuticals ,Ltd
Goa
12.2020 - 05.2022
- Maintain an adherence to the cGMP
- Review, Logging and tracking of Change Control and CAPA
- Responding to queries, follow up for implementation, review and closing of change control and CAPA
- Preparation and review of trends for change control
- Co-ordination with stakeholder for effectiveness verification of Change Control and CAPA
- Validation initiation through validation tracker and remove Block
- Obtaining approval from QP/MAH/MTO/Canada and South Africa regulatory Concerned wherever applicable for relevant QMS
- Online review of document like sequential log book record, temperature, pressure, % humidity record & E-log on monthly basis
- Any other assignment allocated by Head unit Quality assurance.
Executive
Micro Labs Limited
Bangalore
09.2018 - 11.2020
- Preparation of APQR (Annual Product Quality Review) and Graphical and Statistical Evaluation by minitab18 software
- Usage of 'SAP' System for Creation of 'BOM' (Bill of Material) and Issuance of Batch Manufacturing Record and Batch Packing Record
- Issuance, Management and Co-ordination of Change Control's, CAPA and Risk Assessment
- Usage of SAP for review and Approval of Export orders and Product pack Specification
- Conduct the supplier Assessment ensure the supplier performance to quality and regulatory requirement through qualification and prepare & Update approve vendor list
- Co-ordination with other departments for Change Control activities
- Co-ordination with cross functional team for approval and closure of change control
- Review of Artwork for new and Existing Products
- Creation of Item code of New and Revised Artworks
- Handling product document code list.
Education
M. Pharmacy (Quality Assurance) - Quality Assurance
Bharati Vidyapeeth's College of Pharmacy.
Kolhapur, India 06.2016 - 06.2018
Bachelors of Pharmacy - Pharmaceutical
Bharati Vidyapeeth's College of Pharmacy
Kolhapur 06.2012 - 05.2016
Skills
Regulatory compliance
Quality Management System
Corrective and Preventive Action (CAPA)
Change Control Management (CC)
Auditing
Computerized System Validation (CSV)
Risk assessment
Deviation management
Vendor management
Electronic Document management system
Electronic Quality management system (Trackwise),
Electronic Training management system (SABA, SAP Success factor)
Academic Research Publications
Reviewed Paper Publication on Development of an analytical method for assessment of liverbased ex-vivo metabolic profiling of Pazopanib in IJARD
Extracurricular Activities
Worked as an active member of the "National Service Scheme" in 2013-2014. Organized and managed various cultural & sports events in B. Pharmacy.
Disclaimer
I hereby declare that all the details furnished above are true to the best of my knowledge.
Timeline
Executive Officer (QMS)
Serum institute of India Pvt Ltd
09.2022 - Current
Senior Officer
Glenmark Pharmaceuticals ,Ltd
12.2020 - 05.2022
Executive
Micro Labs Limited
09.2018 - 11.2020
M. Pharmacy (Quality Assurance) - Quality Assurance
Bharati Vidyapeeth's College of Pharmacy.
06.2016 - 06.2018
Bachelors of Pharmacy - Pharmaceutical
Bharati Vidyapeeth's College of Pharmacy
06.2012 - 05.2016
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