Indra Kumar
Ahmedabad
Summary
To be part of an organization where growth and perspectives are unlimited, where I can enhance and integrate my knowledge and skill to grow with the organization.
Overview
4
4
years of professional experience
Work History
Executive
Intas biopharmaceutical limited
Ahmedabad
11.2022 - Current
- Handling of QMS, BPCR & MPCR review and preparation
- Inititian of change control CAPA Deviation
Officer
Aculife Healthcare Private Limited
Ahmedabad
08.2021 - 11.2022
- Company Overview: located at Sachana Viramgam road Ahmedabad
- Working in Injectable unit manufacturing of large volume parenteral and small volume parenteral
- Change control deviation CAPA (Ample logic handling)
- Located at Sachana Viramgam road Ahmedabad
Trainee Officer (production)
Galentic Pharma Private Limited
Gandhidham
11.2020 - 08.2021
- Company Overview: Manufacturer of sterile and non –sterile Product
- Working in Aseptic area for manufacturing and filling of sterile ophthalmic product
- Aseptic Batch Filling of Parenteral products
- Aseptic Process Simulation (Media Fill)
- To ensure that O-RABS is in working condition
- To ensure that O-RABS is clean and sterilize before filling activity
- To ensure that glove integrity is in working condition & glove integrity performed before sterilization
- To check the online Leak test, Head space & Crimping height during filling activity
- Aseptic Batch Manufacturing and its related activity
- Aseptic Process Simulation (Media Fill)
- Aseptic Batch Filling
- Autoclave Operation
- CIP & SIP System
- BMR and BPR preparation
- SOP preparation, and its related activity
- Maintains cGMP practices along with documentation in various records
- Imparts on job/ Classroom training to the workmen for SOP and cGMP systems
- Handling of CAPA, Change control and Deviation
- More than 30 deviation investigation experience
- Handling training related documents assign as trainee coordinator
- Manufacturer of sterile and non –sterile Product
- INSRRUMENT HANDLING: Nordern Packing Machine, Bosch filing machine, Autoclave, PH meter, Vacuum leak test, NKP washing and Tunnel
Education
Bachelor of Pharmacy -
Veerayatan institute of pharmacy
09.2020
HSC -
Sri radha Krishna Goinka College
03.2016
SSC -
Sri Mathura High School
03.2013
Skills
- Quick learner
- Ability to work as a team player and individual
- Good communication skill
- Enthusiastic
- Confident
Roles And Responsibilities
- Aseptic Batch Filling of Parenteral products.
- Aseptic Process Simulation (Media Fill).
- To ensure that O-RABS is in working condition.
- To ensure that O-RABS is clean and sterilized before filling activity.
- To ensure that glove integrity is in working condition & glove integrity performed before sterilization.
- To check the online Leak test, Head space & Crimping height during filling activity.
- Aseptic Batch Manufacturing and its related activity.
- Autoclave Operation.
- CIP & SIP System.
- BMR and BPR preparation.
- SOP preparation, and its related activity.
- Maintains cGMP practices along with documentation in various records.
- Imparts on job/Classroom training to the workmen for SOP and cGMP systems.
- Handling of CAPA, Change control and Deviation.
- More than 30 deviation investigation experience.
- Handling training related documents assigned as trainee coordinator.
Technical Knowledge
- Handling of Autoclave,Make:-Pharmalab
- Handling of FFSfilling machine, Make- weiler.
- Handling of Dry Heat Sterilizer,Make:- Fedegari
- Handling of Vial and Bottle Washing Machine, Make:-Mistry engineering.
- Handling of Filter Integrity Testing Machine, Make:-Sartocheck 4plus
- Handling of Manufacturing tank, Make:-Adam, Bright Pharma
- Handling of vial & Bottle filling and Sealing machine, Make:-Groninger.
- Handling of In process instruments like leak test apparatus, Make:-Ketan
- Knowledge on CIP & SIP, sterilization and cleaning techniques.
- Daily practices of cleaning, sanitation and fogging activities.
Auditexposure
- ISO
- USFDA
- WHO
- EU
- ENVISA
- CUSTOMER AUDITS
Computer Skills
- Office Suite : MS-office, MS-Word, Excel, Power point.
- Operating Systems : Windows98, XP,7,8.1,10
Languages
- English
- Hindi
- Gujrati
Disclaimer
I hereby declare that all the information mentioned above is correct and complete to the best of my knowledge and belief.
Personal Information
- Father's Name: Mr. Nagendra Prasad Sah
- Date of Birth: 02/06/97
- Gender: Male
- Nationality: Indian
- Marital Status: Unmarried
Timeline
Executive
Intas biopharmaceutical limited
11.2022 - Current
Officer
Aculife Healthcare Private Limited
08.2021 - 11.2022
Trainee Officer (production)
Galentic Pharma Private Limited
11.2020 - 08.2021
Bachelor of Pharmacy -
Veerayatan institute of pharmacy
HSC -
Sri radha Krishna Goinka College
SSC -
Sri Mathura High School
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