Shivaprasad Itagi
Quality specialist officer -II
Bangalore
Summary
I define myself as a confident, creative person who constantly looks forward to improvisation. Dedication with strong determination is my policy towards work. Rich experience of 4.7 years as Quality compliance team looking for an opportunity where my potential could be used for the growth of the organization as well as individual career and stand as an exemplary in my contribution to the best of my ability to the organization.
Overview
5
5
years of professional experience
4
4
Languages
Work History
Quality specialist officer – II
Medreich pharmaceutical company (Meiji)
03.2021 - Current
- Currently working as a Quality specialist officer – II at Medreich pharmaceutical company (Meiji) Hoskote, Bangalore from march 2021 to till date having 4.7 years in pharmaceutical Quality Assurance department.
- Ensuring cGMP Compliance in the shop floor.
- Giving line clearance to all critical stages from the dispensing, manufacturing to packing activity.
- In process Quality Assurance checks during dispensing, manufacturing and packing activities.
- Issuance of batch records, formats, logbooks and documents control storage as well as archiving of documents as per approved procedure as evidence of the quality.
- Verification of weighing balances.
- Releasing of process order through SAP.
- Releasing of BMR/BPR and PO through SAP system.
- Updating the CV/PV and Hold time study reports.
- Updating and verifying the stage wise APQR data in QLMS and SAP.
- Compilation and approvals of PQR data in QLMS and SAP.
- Complete Review of the executed Batch Manufacturing Records and Batch Packing Records.
- Prepared and revised SOPs and monitored activities compliance to SOPs.
- Tracking of Preventive Maintenance, calibration and qualification status of equipment and instruments present in the shop floor.
- Monitored and verifying the (Environmental monitoring system) environmental conditions on a daily basis through PiSCADA application through SAP system.
- Regulatory compliance (WHO-GMP, USFDA, EU-GMP)
- -Vendor selection and onboarding.
- Doing online documentation of related analysis with updating of appropriate logs.
- Ensuring the Good laboratory and good documentation practices.
- Audit preparations during customers and regulatory audits specification.
- Risk management and mitigation...
- Documentation and record-keepingCross-functional collaboration (QA, procurement, etc.)Continuous monitoring and improvement.
Education
M.Sc - General chemistry
Sri, sai correspondence college Bangalore
Bangalore01-2023
Bachelor of science - undefined
Government Arts and Science college, Karwar
Karwar01-2020
Intermediate (PUC) - undefined
Morarji Desai RES PU college, yellapur UK Dist.
yellapur UK Dist.01-2016
SSLC - undefined
Morarji Desai RES school Ganjigatti, shiggagon taluk
shiggagon taluk01-2014
Skills
SAP (MM)
DMS
QLMS
Micro soft Excel
Micro soft word
Declaration
I hereby declare that the above information furnished is true to the best of my knowledge Place: Bangalore Signature :(Shivaprasad Itagi)
Regulatory Audit faced
- TGA(Australia)
- ANSM(France)
- PMDA(Japan)
- CDSCO(India)
- SFDA(Saudi Arabia)
Personal details
- Father’s Name: Subhash Itagi
- Mother’s Name: Kamalavva Itagi
- Date of Birth: 1998-03-29
- Gender: Male
- Nationality: Indian
- Marital Status: Unmarried
- Communication Address: At/post Magali Tq/shiggaon Dis/Haveri Pincode-581205
Timeline
Quality specialist officer – II
Medreich pharmaceutical company (Meiji)
03.2021 - Current
M.Sc - General chemistry
Sri, sai correspondence college Bangalore
Bachelor of science - undefined
Government Arts and Science college, Karwar
Intermediate (PUC) - undefined
Morarji Desai RES PU college, yellapur UK Dist.
SSLC - undefined
Morarji Desai RES school Ganjigatti, shiggagon taluk