Samba Siva Rao Mamidi
Srikakulam
Overview
2
2
Languages
10
10
years of professional experience
Work History
Quality Assurance - Assistant Manager
Biocon Ltd
Hyderabad
03.2022 - Current
- Monitoring of manufacturing, and packaging activities to ensure compliance with cGMP and SOPs.
- Provided line clearance to ensure production compliance and performing in-process checks.
- Verification of critical process steps, equipment status, and material usage.
- Coordinated handling of deviations, change controls, and incidents with QA/QC and production to maintain compliance.
- Ensuring data integrity and timely documentation during all operations.
- Supporting validation activities (cleaning, process, equipment).
- Reviewed quality documents including master batch manufacturing record (BMR), packing and dispatch records (PDRs), and ECCs to ensure accuracy and adherence to standards.
- Managed dispatch activities to ensure timely shipment of products.
- Review of Annual Product Quality Reports.
- Review of Audit trails for manufacturing computerized systems.
- Issued various documents/records (standard operating procedures, equipment operating procedures, equipment cleaning checklists, etc.) to cross-functional teams to support operational needs.
- Operating the E-BPR in MES system and checking the recipe designs.
- Monitoring the simulations of recipe designs in MES.
Manufacturing - Chemist
Granules India Limited
07.2016 - 12.2021
- Carryout batch process as per BPR without deviation.
- Carry out batch process as per BPR without deviation.
- Ensured adherence to environmental standards in the manufacturing area.
- Raised and received raw materials from warehouse, verifying batch labels for compliance.
- Follow the safety and carry out the total production activities.
- Operating the equipment through DCS system.
- Co-ordination with maintenance department to rectify the mechanical problems of equipment's without affecting production schedule.
- Monitored concentrations during critical operations to ensure compliance with standards.
- Faced multiple regulatory audits, including USFDA and ANVISA, achieving zero observations.
Education
B.Sc - MPC
GOVERNMENT DEGREE COLLEGE
PATHAPATNAMIntermediate - MPC
GOVERNMENT JUNIOR COLLEGE
PATHAPATNAMS.S.C -
Z.P. HIGH SCHOOL
NIVAGAMSkills
- CGMP and GDP Compliance
- Validation support
- Batch release review
- Deviation management
- Line clearance checks
- Audit readiness
- Risk Management
- SAP
- MS excel
- MS word
Accomplishments
Successfully faced multiple Regulatory audits i.e. USFDA, ANVISA with zero observations.
Languages
- Telugu
- English
Personal Information
Date of Birth: 12/02/95
Languages
English
Beginner
A1
Telugu
Beginner
A1
Timeline
Quality Assurance - Assistant Manager
Biocon Ltd
03.2022 - Current
Manufacturing - Chemist
Granules India Limited
07.2016 - 12.2021
B.Sc - MPC
GOVERNMENT DEGREE COLLEGE
Intermediate - MPC
GOVERNMENT JUNIOR COLLEGE
S.S.C -
Z.P. HIGH SCHOOL