Sudula Sudharshan Reddy
Beeramguda,TS
Summary
A seasoned quality assurance professional with about 16.0 years in pharmaceutical quality assurance, specializing in GMP and regulatory compliance. Currently leading QA & DQA departments at Auro peptides Ltd, previously held leadership roles at SUN PHARMA and Alembic Pharma, with expertise in quality systems, quality audits, Supplier quality management and continuous improvement. Holds a Ph.D. in Organic chemistry, known for implementing SOPs, Guidelines, managing complex documentation, and supporting regulatory submission across global standards. Skilled in SAP, EDMS, LMS, Track-wise and multiple compliance system, with a proactive approach to quality assurance and regulations.
Overview
16
16
years of professional experience
Work History
DQA&QA-Senior-Manger
Auro peptides Ltd., Hyderabad (A subsidiary of Aurobindo Pharma)
08.2023 - Current
- Ensure Quality system, cGMP and ICH guidelines are followed at site. Conduct annual analysis of upgrades to quality system in terms of both operations efficacy as well as new FDA or ICH regulatory changes.
- Author / Review the SOPs/work directions required for implementing the Quality Systems (R&D) activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions.
- Manage customer Quality audits and vendor qualification related activities as per local and global requirements in compliance with regulatory and policies.
- Drive continuous improvement initiatives in QA systems, processes, and documentation related to R&D quality support.
CMC-QA, Manager-I
Sun Pharmaceutical Industries Limited
07.2020 - 08.2023
- Lead QA review and approval of method validation/transfer protocols and reports for methods transitioning from internal R&D to CMOs for registration and validation purposes, and between CMOs as part of horizontal Tech Transfer activities.
- Supporting BD by releasing of batch release and providing its supporting documents to customers.
- Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs, templates and style guidelines.
- Oversaw recruitment, hiring, and on boarding processes, trained new team members in operational procedures, and conducted performance reviews.
- Approval technology transfer documents (development reports, Process package, Structure elucidation report, sameness reports and review of DMF filling and ANDA related documents.
- Conducting of onsite audits of Contact testing Laboratories which are used for Peptide-APIs divisions.
- Ensure audit readiness of manufacturing site and R&D site for USFDA / EU inspection /customer audits / any other authorities.
- Responsible review and approval of documents such as SOPs, master formula cards, validation protocols, validation reports.
- Perform cGMP audit of manufacturing facility and operations. Assist the team in auditing contract manufacturers / vendors / contract testing laboratory.
- Participate in handling of Out of Specification, Out of Trends, Deviation, Batch failure, Rejections, investigations and CAPA implementation at site
- Contribute towards process excellence; provide input into regular review of departmental SOPs and guidelines.
- Approval of Master documents (BPR/Master formula/Process flow/SOP/Spec & MOAs, master formula card, process validation protocol and Process validation report etc.) of products.
- Accountabilities in SUN-PHARMA (R&D-Quality-QA);
QA-Senior Research Scientist
Alembic Pharmaceuticals Ltd.
06.2017 - 07.2020
- Initially joined in a a R&D as a Research Scientist (Team leader), worked on various APIs and supported for various DMF fillings. After two years internally transferred to QA department (peptide).
- Setup of Research and development centre at Hyderabad with respect to the quality system and local FDA requirement.
- Faced audit of local FDA for new approval of facility and renewal of facilities.
- Review and approve development related QMS SOPs and documents like change control, incident, CAPA, etc.
- Review and approve the development related documents like MFC, MPC, Specification and STP of Drug products, drug substances, Intermediates and Raw materials.
- Review and approve technology development reports for drug products and drug substances.
- Review and approval of analytical method development report along with supporting raw data.
- Review and approval of impurity characterization data and working standard qualification data.
- Approval of protocol for analytical method validation, analytical method equivalence, and analytical method transfer activities for drug substances, drug products, drug intermediates and raw materials.
- Approval of report for analytical method validation and analytical method equivalence activities for drug substances, drug products, drug intermediates and raw materials along with related raw data.
- Provide the training to the new joiners in R&D centre and conduct training program as and when required.
- Evaluation of Vendor Qualification for Key starting materials, intermediates, Excipients, Packaging materials etc. which are related to R&D prospect.
- Handling of software:
- Implementation of Document control system at R&D: For the preparation and review of documents, upload the vendor related documents in system etc.
- Implementation of SAP: For the generation of material code, verification of code
- Implementation of Sample test management system (STMS): For the handling of R&D related test request cum report.
- Implementation of LMS (Learning Management System): For training of R&D employee and maintenance of electronic training record.
- Evaluation of third party for the computer system validation of Analytical instruments.
- Involved in the computer system validation of Analytical Instruments
- Review and approval of computer system validation protocol and reports
- Auditing of Manufacturer/supplier & service providers:
- Conducting of onsite audits of domestic suppliers of API, Advance Intermediates, KSM, and Contact Testing Laboratories which are used for APIs divisions.
- Accountabilities in ALEMBIC PHARMA, DQA-Hyderabad, India
Senior Research Scientist
Alembic Pharmaceuticals Ltd.
09.2015 - 06.2017
- Participate in Control strategy and assessment of route of Synthesis for identification of possible impurities may arise from starting materials or during process (ICHQ3C, ICHQ3D and M7).
- Phase gate clearance for the product development, ensuring QbD requirements & Statical evaluation by using PI-Software (21st century quality).
- Approval activities of Process package, Process Development report and evaluation of the CPPs and CQAs
- Participation in meetings, Review, and approval of risk assessment for drug substances and drug products (Product development Risk assessment, Nitrosamine and Elemental analysis) through PI software and FMEA.
- Participate in handling of Out of Specification, Out of Trends, Deviation, Batch failure, Rejections, investigations and CAPA implementation at site
- QMS related activities (deviation, Incidents and Change Control related activities through track-wise) for their compliance with respect to the regulatory submissions.
- Vendor Qualification of outsource API-vendors by reviewing the DMF and TDP for Key starting materials, intermediates, Excipients, Packaging materials etc. which are related to R&D prospect.
R&D-Team leader
Zhejiang Menovo Pharmaceutical Co. Ltd
02.2014 - 08.2015
Executive
Panacea Biotech Ltd.
01.2012 - 02.2014
Chemist
USV Pharmaceuticals Ltd., (Erstwhile Bharavilaboratories (P) Ltd.)
07.2009 - 12.2011
Education
Ph.D. - Synthesis, Characterization and Biological screening of some novel heterocyclic compounds
Chaitanya Deemed to be university
Telangana, India01.2023
M.Sc. - Organic Chemistry
Osmania University
Telangana, India01.2009
Skills
- LIMS 503
- DCS (Document control System)
- EDMS (Electronic document system)
- Track wise
- SAP –HANA &MDM
Languages
English
Hindi
Telugu
Timeline
DQA&QA-Senior-Manger
Auro peptides Ltd., Hyderabad (A subsidiary of Aurobindo Pharma)
08.2023 - Current
CMC-QA, Manager-I
Sun Pharmaceutical Industries Limited
07.2020 - 08.2023
QA-Senior Research Scientist
Alembic Pharmaceuticals Ltd.
06.2017 - 07.2020
Senior Research Scientist
Alembic Pharmaceuticals Ltd.
09.2015 - 06.2017
R&D-Team leader
Zhejiang Menovo Pharmaceutical Co. Ltd
02.2014 - 08.2015
Executive
Panacea Biotech Ltd.
01.2012 - 02.2014
Chemist
USV Pharmaceuticals Ltd., (Erstwhile Bharavilaboratories (P) Ltd.)
07.2009 - 12.2011
M.Sc. - Organic Chemistry
Osmania University
Ph.D. - Synthesis, Characterization and Biological screening of some novel heterocyclic compounds
Chaitanya Deemed to be university
Publications (Patents and papers)
- Novel polymorphic forms of Lenvatinib mesylate and preparation Processof Lenvatinib mesylate (IN201621036255A) Authors: Siri Pragada Mahender Rao, Patil Kishore, Reddy Sudharshan, Kumar Rajeev, Patel Kamlesh, Ladani Mahesh, Viral Parekh, Thakor Indrajit.
- Preparation of Obeticholic acid (WO/2018/220513) Authors: Siri Pragada Mahender Rao, Tomar Sanjiv, Patel Nilav, Sudhir Shah, Reddy Sudharshan, Sharma Dhaval
- Preparation of Osimertinib mesylate (IN20121000752A), (IN201710020919A) Authors: Siri Pragada Mahender Rao, Reddy Sudharshan, Patel Kamlesh, Patel Pradeep, Ladani Mahesh, Parekh viral, Thakor Indrajit.
- One pot synthesis of new N-allyl and N-benzyl quinazolinones and their anti-inflammatory activity Authors: Sudharshan Reddy Sudula, Ranjith Jala, Kavitha Siddoju, Jagadeesh Kumar Ega- Journal of the Indian Chemical Society 98 (2021)100033.
- Synthesis, Characterization and Antimicrobial activity of some novel 1-Cyclo propyl-6-Fluoro-8-methoxy-7-Substituted-4-oxo-1,4-Dihydroquinolin-3-Carboxylic acid. Authors: Sudula Sudharshan Reddy, Jagadeesh Kumar Ega