Monika Kumari
Baddi
Summary
Results-driven Quality Assurance- Senior Officer successful at coordinating in Review of documents and SAP activities. Familiar with managing multiple areas of operation such as Review of Master BMR, Master BPR, Process Validation Protocols, Review of SOPs, SAP activities, Issuance of BMR and BPR etc.
Ready to bring more than 8 years experience to a new role with growth potential.
Overview
9
9
years of professional experience
Work History
Senior Officer- Quality Assurance
FDC Limited Baddi
Baddi
01.2024 - Current
- SOP preparation, Review and training of SOPs.
- Management of Control Samples
Technical Assistant Quality Assurance
Torrent Pharmaceuticals Limited
Baddi
02.2015 - 12.2023
- Review of Manufacturing and Packing Process Validation Protocol as well as Reports.
- Preparation & Review of Validation Master Plan Annexure IV for Process Validation.
- Review of Risk Assessment for Manufacturing Process Validation Protocols.
- Review of Master Formula Card, Master Batch Manufacturing Record and Master Batch Packing Record.
- Preparation and Review of Standard Operating Procedures for Documentation
- Blocking and unblocking of Material in SAP.
- Checking and Approval of Recipe of Master Batch Manufacturing Record as well as Master Batch Packing Record in SAP.
- Issuance and Retrieval of Batch Manufacturing Record and Batch Packing Record for Products.
- Issuance, Review and Retrieval of Logbooks, Formats, Daily Records to all departments in organisation.
- Handling of Executed Dockets.
- Handle the technology transfer documents including the site transfer of products from other plants to baddi or transfer of products from baddi to others.
- Handling of customer queries related to Batch Manufacturing Record and Batch Packing Record.
- Sharing of dockets as per customer requirements
- Training of new joined employee and training as per yearly training calendar.
- SOP preparation and training of SOPs.
- SOP Effective and upload in TMS.
- Carrying out IPQA activities in each stage ofManufacturing.
- Monitoring of In-process quality parameters of Granulation, Compression, and Coating.
- Verification of Quantity of Raw Material for Dispensing.
Education
Bachelor of Pharmacy - Pharmaceutics
Sai Ram Education Trust, Hamirpur
Hamirpur 07-2014
Senior Secondary Education - Medical
Kendriya Vidyalaya Khairi
Khairi06-2009
Secondary Education - English, Hindi, Maths, Science And Social Science
Kendriya Vidyalaya Khairi
Khairi06-2007
Skills
- Conversant with Adobe Acrobat Writer
- Knowledge of SAP
- Knowledge of Training Management System
- Knowledge of Track wise System
- Conversant with MS-Office Applications (Word, Excel & PowerPoint)
Languages
English
Elementary
A2
Hindi
Upper Intermediate
B2
Punjabi
Beginner
A1
Personal Details
- Date of Birth: 01st May 1991.
- Marital Status : Married
- Correspond Address : House No. 34 Phase 1, Near ESIC Office, Baddi (HP)
- Permanent Address: VPO Mehkar, Teh. Nurpur Dist. Kangra (HP)
Declaration
I hereby declare that the information furnished above is true to the best of my knowledge.
Monika Kumari
Timeline
Senior Officer- Quality Assurance
FDC Limited Baddi
01.2024 - Current
Technical Assistant Quality Assurance
Torrent Pharmaceuticals Limited
02.2015 - 12.2023
Bachelor of Pharmacy - Pharmaceutics
Sai Ram Education Trust, Hamirpur
Senior Secondary Education - Medical
Kendriya Vidyalaya Khairi
Secondary Education - English, Hindi, Maths, Science And Social Science
Kendriya Vidyalaya Khairi
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