Jayarami Reddy Cheedipudi
Vizianagaram
Summary
To achieve a responsible position that fosters creativity and innovation through trust, flexibility and freedom to work towards organizational goals for a Quality Product, Patient Safety and benefits coupled with Career Orientations.
17 years of experience in Quality Control function and AR&D of pharmaceutical industry.
Overview
17
17
years of professional experience
Work History
Section Head in QC
Dr. Reddy’s laboratories limited
07.2014 - Current
- Company Overview: FTO SEZ, Process Unit-1, Pydibheemavaram, Srikakulam, Andhra Pradesh, India
- Responsible for timely launch of “New Products” and Regulatory Filing Requirements
- Responsible for Exhibit, Hold Time, Trail batches, Validation, Swab and GC teams
- Managing QMS elements such as incidents, OOS, OOT, CAPA and Change Controls
- Co-ordination with IPDO team for new products
- Handled Finished product section and maintained TAT, SPA and SLA compliance as per management requirements
- Managing analytical method transfers, method validations and method verification activities
- Troubleshooting of Analytical methods
- Experience in Handling of critical analytical instruments such as HPLC, GC, GCMS, LCMS, Capillary Electrophoresis (CE) and IC instruments
- Good experience in Empower, LIMS and Chromeleon software
- To Motivate Team and Monitor closely analysis time cycles to enhance the instrument productivity and Man hours
- Responsible for lab audits and compliance in QC and compiling the audit response and ensuring proper execution of the commitments as per the agreed timelines
- Adhered to QC related activities with compliance
- FTO SEZ, Process Unit-1, Pydibheemavaram, Srikakulam, Andhra Pradesh, India
QC officer
CIPLA limited
11.2009 - 07.2014
- Company Overview: Sterile formulations Unit-IX, Goa India
- Planning and Execution of analytical method transfers, method validations and method Verification activities for injectable formulations and powder for oral solutions
- Handled market compliant samples with investigations
- Execution of Diluted Solution Studies for Injectable
- Responsible for maintenance of documents and instruments as per GLP requirements
- Sterile formulations Unit-IX, Goa India
Research associate, AR&D
Enaltec labs
12.2007 - 11.2009
- Company Overview: Navi Mumbai
- Execution of method developments and method validations for API
- Preparation of Analytical Test methods
- Execution of routine analysis samples
- Handled Analytical Instruments such as HPLC, GC, UV, IR, etc
- Navi Mumbai
Education
M.SC - ORGANIC CHEMISTRY
ASN College
Tenali, Andhra Pradesh01.2005
B.SC - CHEMISTRY
Andhra Loyola College
Vijayawada, Andhra Pradesh01.2003
Skills
- Quality Control operations
- Laboratory Investigations
- OOS
- OOT
- Change management
- CAPA
- Analytical method validations
- Analytical method verification
- Analytical method transfers
- Technical skills
- Problem solving
- Exhibit batches
- Trial batches
- Validation batches
- Investigations
- Feasibility evaluation report
- Commercial batches releases
- Cross functional teams
- RM/IP/FP/Exhibits sections handling
Exposure To Regulatory Audits
- USFDA
- MHRA
- ANVISA (Brazil)
- Romania
- TGA
- WHO drug controller audits
- Various customer based audits at site level
Personal Information
- Date of Birth: 08/04/83
- Marital Status: Married
Job Profile
Dr. Reddy’s Laboratories Limited, FTO SEZ, Unit-1, Srikakulam, Andhra Pradesh, India, Responsible for timely launch of 'New Products' and Regulatory Filing Requirements, Responsible for Exhibit, Hold Time, Trail batches, Validation, Swab and GC teams, Managing QMS elements such as incidents, OOS, OOT, CAPA and Change Controls, Co-ordination with IPDO team for new products, Handled Finished product section and maintained TAT, SPA and SLA compliance as per management requirements, Managing analytical method transfers, method validations and method verification activities, Troubleshooting of Analytical methods, Experience in Handling of critical analytical instruments such as HPLC, GC, GCMS, LCMS, Capillary Electrophoresis (CE) and IC instruments, Good experience in Empower, LIMS and Chromeleon software, To Motivate Team and Monitor closely analysis time cycles to enhance the instrument productivity and Man hours, Responsible for lab audits and compliance in QC and compiling the audit response and ensuring proper execution of the commitments as per the agreed timelines, Adhered to QC related activities with compliance, CIPLA Limited, Sterile Formulations Unit-IX, Goa, India, Planning and Execution of analytical method transfers, method validations and method Verification activities for injectable formulations and powder for oral solutions, Handled market compliant samples with investigations, Execution of Diluted Solution Studies for Injectable, Responsible for maintenance of documents and instruments as per GLP requirements, Enaltec Labs, Navi Mumbai, India, Execution of method developments and method validations for API, Preparation of Analytical Test methods, Execution of routine analysis samples, Handled Analytical Instruments such as HPLC, GC, UV, IR, etc.
Timeline
Section Head in QC
Dr. Reddy’s laboratories limited
07.2014 - Current
QC officer
CIPLA limited
11.2009 - 07.2014
Research associate, AR&D
Enaltec labs
12.2007 - 11.2009
M.SC - ORGANIC CHEMISTRY
ASN College
B.SC - CHEMISTRY
Andhra Loyola College
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