Ganji Ramana Reddy
Hyderabad,TS
Summary
Accomplished Quality professional skilled in data integrity, crisis management, and training and development, with a strong focus on continuous improvement and regulatory compliance. Career goals include further advancing leadership capabilities within the pharmaceutical industry while driving innovation in quality control processes.
Dedicated Techno Quality professional with experience in achieving tangible results and cross-team collaboration. Proactive and excited to partner with like-minded individuals to achieve goals.
Overview
22
22
years of professional experience
Work History
Sr. General Manager-Quality (for QC-Cluster head)
Enzene Biosciences
12.2024 - Current
- Company Overview: A Alkem group company
- Responsible for day to day operations of quality control laboratory including Stability, Analytical development, microbiology, method validations with a team of 135 plus analysts across the sites.
- Responsible for managing entire QC (across sites) including resolving the day to day problems, meeting the organizational goals as well as regulatory agencies.
- Responsible for continuous improvement of overall cGMP compliance in line with the GMP/GLP and regulatory expectations.
- Conceptualizing and implementing effective techniques in increasing the efficiency at workplace.
- Leading validation, planning and manpower allocation, collaborating with external agencies such as CRO/CMO for effective and timely deliverables.
- Conducting Internal audits to ensure the regulatory requirements in procedures, practices, devising an appropriate mechanism to detect risk and minimize the same by mitigating the plan.
- Providing training to the analysts on SOP’s and GLP on timely manner.
- Proficient with LIMS, SAP, EMPOWER and all other laboratory softwares.
Gen. Manager
Aspiro Pharma Limited
09.2019 - 12.2025
- Company Overview: A Hetero group company
- Responsible for day to day operations of quality control laboratory including Stability, Analytical development with a team of 200 plus analysts.
- Responsible for managing entire QC including resolving the day to day problems, meeting the organizational goals as well as regulatory agencies.
- Responsible for continuous improvement of overall cGMP compliance in line with the GMP/GLP and regulatory expectations.
- Preparation, Review and monitoring of QMS documents such as incidents, CAPA, OOS, OOT, market complaints, SOP’s, STP’s, implementation of new technologies in quality control laboratory.
- Conceptualizing and implementing effective techniques in increasing the efficiency at workplace.
- Leading validation, planning and manpower allocation, collaborating with external agencies such as CRO/CMO for effective and timely deliverables.
- Conducting Internal audits to ensure the regulatory requirements in procedures, practices, devising an appropriate mechanism to detect risk and minimize the same by mitigating the plan.
- Preparing appropriate trend analysis and annual product reviews pertaining to laboratory activities to assess the GAP’s and implementing appropriate CAPA in timely manner.
- Providing training to the analysts on SOP’s and GLP on timely manner.
- Proficient with LIMS, SAP, EMPOWER and all other laboratory softwares.
Asst. Gen. Manager
Aspiro Pharma Limited
12.2015 - 09.2019
- Company Overview: A Hetero group company
- Established central R&D center for sterile formulations (Oncology, Non-Oncology, Eye Drops, and Hormones) at Hetero drugs.
- As Head, QA responsible for establishing, maintaining and taking care of all quality aspects in R&D and manufacturing location.
- Leading a team of about 30 members, who are responsible for handling all the quality aspects for different R&D centers located in Hyderabad.
- Coordinating with all the cross functional teams for project review and updating to the management.
- Responsible for conducting internal audits within the R&D dept., Manufacturing locations and vendor site audits located in different places along with customer locations.
- Track progress of projects within agreed timelines including technology transfer of the products to different manufacturing locations.
- Assign and perform training and development goals to the group.
- Reviewing and Approving SOPs., Method development reports, Method validation Reports, PDR's, Regulatory responses Etc…
Sr. Manager
Aizant Drug Research Solutions
03.2013 - 11.2015
- Sr. Manager at Aizant Drug Research Solutions, heading the AR&D department Leading a Team of about 60 Scientists comprising different levels of Scientists includes 05 team leaders working on various types of projects for Solid Oral dosage forms, Liquid Dosage forms, injectables etc.
- Responsible for day to day activities of AR&D lab in Aizant Drug Research solutions, monitoring a team of 30 Scientists for carrying out all AR&D activities such as Method development, Method validations, Routing and Stability analysis etc. for NDA/ ANDA/ EU dossiers etc.
- Coordinating with Different depts. such as Formulation R&D, Project management, supply chain management, procurement, administration, engineering etc. along Clients for timely completion of projects and completing their tech transfer.
Sr. Manager
Pulse Pharmaceuticals Pvt. Ltd.
03.2012 - 03.2013
- As a Sr. Manager at Pulse pharmaceuticals, established and commissioned new cGMP AR&D Lab.
- Responsible for day to day activities of AR&D lab, monitoring a team of 15 Scientists for carrying out all AR&D activities such as Method development, Method validations, Routing and Stability analysis etc.
- Budgeting, Indenting and Procuring Instruments and their IQ, OQ, PQ, upon receipt
- Executing new projects in co-ordination with management, Clients and other depts.
- Successfully completed about 15 projects for domestic market in a span of one year.
- Monitoring method development, method validation, method transfer, and stability tests as per EP, USP and ICH guidelines
- Monitoring the Analytical Method Transfers between the Manufacturing Plants
- Track progress of projects within agreed timelines.
- Assign responsibilities within the group and Dept.
- Document all laboratory work to meet Regulatory standards
- Collect, analyze and interpret data, keep records of experiments including results and conclusions, recognize aberrant results and data trends, and provide plausible explanations including plans for follow up experiments to clarify findings.
- Assign and perform training and development goals to the group.
- Reviewing and Approving SOPs., Method development reports, Method validation Reports, Etc…
Research Scientist
Aurobindo Pharma Ltd. Research Center
01.2007 - 03.2012
- As a Research Scientist at Aurobindo Pharma Ltd. Research Center since January-2007 to March-2012. in ANDA AR&D Department
Executive in Analytical Development
Biocon Ltd
08.2006 - 01.2007
- As an Executive in Analytical Development in Biocon Ltd, Bangalore since August 2006 to January-2007 in Method Development team.
Executive in Analytical Development
Dr Reddy’s Laboratories Ltd
01.2005 - 08.2006
- As an Executive in Analytical Development in Dr Reddy’s Laboratories Ltd Hyderabad since January 2005 to August 2006 in Method Development, Validation and Troubleshooting Team along with supporting.
Analytical Chemist
Sudarshan Chemicals Ltd
09.2003 - 12.2004
- As an Analytical Chemist in Analytical Development in Sudarshan Chemicals Ltd, Pune since September 2003 to December 2004 in Method Development, Validation and Troubleshooting Team along with supporting.
Education
Ph.D. - Chemistry (Pharmaceutical analysis)
Nagarjuna University
M. Sc. - Analytical Chemistry
Univ. of Pune
Skills
- All Quality Aspects including Data Integrity, Crisis management, Regulatory audits, QMS activities, Smoke studies, Qualifications, Quality Control and R&D establishment
- Expertise in the Investigation mechanisms of various QMS elements (OOS, change controls, Incidents, Deviations, CAPA etc) activities
- Expert in Analytical Method Development and Analytical Method Validations along with support analysis, Stability analysis, Impurity Profiling, Pre-formulation studies
- Knowledge on Formulation development
- Handling of Regulatory and Customer audits
- Handling Vendor Qualifications, SAT(site acceptance) audits for new equipment’s, involving and monitoring end to end quality assurance activities
- Technology transfer at plant location
- Sound knowledge on different documentation process such as BMR, BPR MFC,MPC, PDR, Tech pack, Technology transfer documents, STP's, Specifications, MOA's, Method development reports, Method validation protocols along with reports, technology transfer protocols along with reports, SOP's, GTP's etc…
- Monitoring Complete activities of Quality
- Reviewing of drug master files along with other documents like patents etc…
- Procuring of reference standards, Impurity standards along with other procurements for Depts including Capex items
- Implementation of GXP systems across the depts
- Effective utilization of Equipment, Manpower & Budgetary sanctioned amount
- Regulatory compliance of Analytical Lab
- Training and personality development of Manpower within the dept and cross functional teams including quality control laboratories
- Operating systems : WINDOWS, DOS
- Languages : C, C, VB
- Database : Oracle, MS-Access
Accomplishments
- Resolved the issues (long standing issues from 2023-DI and Compliance ) related to different sections by steering the QC activities and made the laboratory ready for USFDA audit within 6 months, also resulted in MHRA zero observation.
- USFDA Auditor applauded the QC laboratory during the audit for the paperless quality control laboratory of Aspiro pharma (first for hetero group) including empower data migration to LIMS.
- Made quality control laboratory at Aspiro for USFDA audit ready with in 45 days by steering all the policies which resulted in zero observations during the inspection by USFDA and MHRA/Europe audits.
- Key personal from Analytical dept. for working on FTF/Para-IV fillings. Till date worked on 08 FTF/Para-IV projects in Dr reddy s, Aurobindo and Aizant.
- Successfully completed 8 projects at Aizant which are having analytical technical issues and running for more than 4 years with in a span of 6 months by resolving all the technical issues and successfully completed their technology transfer.
- Given Analytical Support for Development of Triple Combination and Double Combination products of ANDA Formulations in Very Short Span of time with Single method for each for quantifying Assay, Dissolution and Related Substances.
- Knowledge about Empower and LC-Solution Server IQ/OQ/PQ and Maintenance including data backup.
- Till date more than 50 ANDA’s/ Dossiers have been submitted in USA and Europe and one of them got PARA-IV approval from USFDA which include solid dosage forms, liquids, suspensions and injections along with oncology.
- Successfully contributed for the building up of infrastructure and Laboratory setups in different organizations. Implemented GLP and many systems for effective functioning of department and to meet the regulatory requirement
Languages Known
English
Bilingual or Proficient (C2)
Hindi
Bilingual or Proficient (C2)
Marathi
Elementary (A2)
Telugu
Bilingual or Proficient (C2)
Publications
Having more than 45 Publications in international repute journals.
References
Available upon request.
Timeline
Sr. General Manager-Quality (for QC-Cluster head)
Enzene Biosciences
12.2024 - Current
Gen. Manager
Aspiro Pharma Limited
09.2019 - 12.2025
Asst. Gen. Manager
Aspiro Pharma Limited
12.2015 - 09.2019
Sr. Manager
Aizant Drug Research Solutions
03.2013 - 11.2015
Sr. Manager
Pulse Pharmaceuticals Pvt. Ltd.
03.2012 - 03.2013
Research Scientist
Aurobindo Pharma Ltd. Research Center
01.2007 - 03.2012
Executive in Analytical Development
Biocon Ltd
08.2006 - 01.2007
Executive in Analytical Development
Dr Reddy’s Laboratories Ltd
01.2005 - 08.2006
Analytical Chemist
Sudarshan Chemicals Ltd
09.2003 - 12.2004
M. Sc. - Analytical Chemistry
Univ. of Pune
Ph.D. - Chemistry (Pharmaceutical analysis)
Nagarjuna University
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