Track wise System
Bhagyshree Sandeep Kore
Executive At Corporate Quality Assurance
Murida Fatorda,GA
Summary
Highly motivated and dedicated professional with a strong passion for the pharmaceutical industry. Seeking to advance career by leveraging exceptional skills, educational background, and extensive knowledge. Thrives on challenges, excels in leading by example, and thrives in innovative and collaborative environments. Committed to making a significant impact and eager to contribute expertise and drive to a dynamic organization within the industry.
Overview
14
14
years of professional experience
5
5
Languages
Work History
Executive
Indoco Corporate Quality Assurance
08.2021 - Current
- Directing procurement and monitoring of raw materials and packaging materials for multiple locations.
- Responsible for Conducting vendor audits of RM and PM
- Evaluation of manufacture of RM and PM for all the six manufacturing locations anally
- Managing SAP system to streamline material management processes.
- Preparation of SOPs and Quality Policies
- Managing quality management systems in vendor operations.
- Managing Fiori application within material master management systems.
- Mentoring junior staff members for accelerated career growth, developing future leaders within the organization.
- Collaborating with stakeholders to develop actionable strategies that aligned with corporate goals and objectives.
- Managed cross-functional teams for successful project completion within budgetary constraints and deadlines.
- Located bottlenecks to streamline existing processes.
QA Executive
Choksi Laboratories
01.2017 - 09.2018
- Performed comprehensive review of analytical reports and instrumentation audit trails for GC, HPLC, ICP-MS, UV, and IR.
- Managed quality management systems within QA.
- Managed distribution process for important documentation.
- Handling of Customer Audits and responsible for compliance of Audits
- Active Participation in Audits done by GOA FDA, Cipla, Teva Pharmaceuticals, Indoco CQA, Fertin, Pfizer, Abbott, Marksans, Zydus Cadila, Lupin and Vergo Pharma in Choksi Laboratories
QA Officer
Indoco Remedies
01.2015 - 06.2016
- Company Overview: Sterile plant
- Handling and monitoring of all IPQA activities as section head
- Preparation & Revision of SOPs
- Documentation review & compilation
- Training coordinator
- Raising change control
- APQR preparation
- Faced two regulatory audits USFDA and MHRA
- Explained Secondary packing system to MHRA Auditor
- Sterile plant
Production Officer
Marksans Pharma LTD
10.2010 - 11.2011
- Preparation of Master Production Control Records
- Supervision of Packing Lines
- Preparation of Daily Production Report
Education
B.PHARM IV - undefined
D.S.T.S. Mandal’s College of pharmacy
SolapurD.PHARM II - undefined
M.S.B.T.E. Board
MumbaiH.S.C. - undefined
Sangameshwarcollege
SolapurS.S.C. - undefined
H.D.High School
SolapurSkills
Optimistic approach
Accomplishments
- Qualified G-PAT 2010 with all INDIA Rank 1619
- Ranked first at college
- Ranked first in medical detailing competition for Ist & IInd year Diploma & IInd, IIIrd & IVth year degree
Areas Of Interest
- Quality Assurance Department
- Regulatory Affairs
- Technology Transfer
Roles And Responsibilities
- Marksans Pharma Ltd, Preparation of Master Production Control Records, Supervision of Packing Lines, Preparation of Daily Production Report
- Indoco Remedies Sterile Plant, Handling and monitoring of all IPQA activities as section head, Preparation & Revision of SOPs, Documentation review & compilation, Training coordinator, Raising change control, APQR preparation, Faced two regulatory audits USFDA and MHRA, Explained Secondary packing system to MHRA Auditor
- Choksi Laboratories, Review of analytical reports and audit trail on GC, HPLC, ICPMS, UV & IR, Handling QMS part of QA department, Issuance of documents, Handling of Customer Audits and responsible for compliance of Audits, Active Participation in Audits done by GOA FDA, Cipla, Teva Pharmaceuticals, Indoco CQA, Fertin, Pfizer, Abbott, Marksans, Zydus Cadila, Lupin and Vergo Pharma in Choksi Laboratories
- Indoco Remedies Corporate Quality Assurance, Responsible for vendor management of RM, PM for all the six manufacturing locations, monitoring of team, Responsible for Conducting vendor audits of RM and PM, Evaluation of manufacture of RM and PM for all the six manufacturing locations anally, Handling of SAP system for material management, Preparation of SOPs and Quality Policies, Responsible for QMS related to vendor management, Handling of Fiori application in Material master management software
Additional Qualifications
- Computers: MS CIT Certificate Course
- Handled ERP software
- Currently handling SAP S4HANA SYSTEM
- MDM SYSTEM
Job Profiles
- Production Officer, Marksans Pharma LTD, Verna Industrial Estate, Verna, Goa, 10/11/10, 11/11
- QA Officer, Indoco Remedies Sterile plant, Verna, Goa, 01/15 to 06/16
- QA Executive, Choksi Lab, 01/17, to 09/18
- Executive ,Indoco Corporate Quality Assurance, since 08/21
Personal Information
- Age: 37
- Date of Birth: 08/13/87
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Software
SAP S4HANA
Document management system
Master data management
Timeline
Executive
Indoco Corporate Quality Assurance
08.2021 - Current
QA Executive
Choksi Laboratories
01.2017 - 09.2018
QA Officer
Indoco Remedies
01.2015 - 06.2016
Production Officer
Marksans Pharma LTD
10.2010 - 11.2011
B.PHARM IV - undefined
D.S.T.S. Mandal’s College of pharmacy
D.PHARM II - undefined
M.S.B.T.E. Board
H.S.C. - undefined
Sangameshwarcollege
S.S.C. - undefined
H.D.High School
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