Prasanna Bharathi Siddula
Hyderabad
Summary
Accomplished Pharma QA Professional with over 18 years of experience in life sciences and regulated IT industries. Proven track record in ensuring compliance with regulatory standards, implementing quality assurance processes, and optimizing system efficiency. Expertise in risk management, audit preparation, and cross-functional collaboration. Committed to driving quality improvements and enhancing operational performance.
Quality Assurance Leader with extensive experience in managing audits and inspections across GCP, GMP, GLP, GxP, and ISO standards. Demonstrated success in implementing robust Quality Management Systems and ensuring compliance with regulatory requirements. Notable achievements include serving as a Global Auditor and Vendor Audit Manager while providing expert training on QA processes. Aiming to leverage expertise to enhance quality assurance practices in a dynamic organization.
Detail-oriented professional with expertise in ICH-GCP, EMEA, and regulatory compliance including MHRA and GMP. Demonstrated proficiency in Quality Risk Management and Data Integrity across various standards such as 21 CFR Part 11 and ISO 9001. Proven track record of ensuring adherence to EU MDR & IVDR regulations while implementing effective quality assurance strategies. Aiming to leverage extensive knowledge to enhance operational efficiencies in a dynamic organization.
Overview
18
18
years of professional experience
Work History
Manager ITN Audit and CAPA
Qinecsa Solutions
London
03.2024 - Current
- Manage a team of Quality specialists and CSV experts. Build and lead a team of validation and IT Quality professionals, providing guidance, training, and support.
- Ensure that quality management policies and procedures adhere to industry standards and governing regulations.
- Maintain the CAPA management process working with different stakeholders to ensure their timely closure.
- Monitor key performance indicators (KPIs) for quality assurance.
- Assist in carrying out the internal audits to assure adherence to the QMS.
- Carry out supplier audits as part of the audit supplier audit schedule.
- Carry out and manage periodic reviews of IT systems and applications.
- Ensure regulatory compliance of GxP systems by the application industry standard regulations, such as FDA 21 CFR Part 11 and GAMP 5, and ensure that computer systems align with these standards.
- Provide Company wide training in the areas of CSV and IT Quality.
- Responsible for performing quality assurance (QA) activities to ensure projects are conducted in accordance with ICH , 21 CFR Part 11, Annex 11 and GAMP and other applicable regulations and company policies and procedures
- Implement security policies and procedures across the organization and implement ISO 27001 standard requirements
- Ensure regulatory compliance of GxP systems by the application industry standard regulations, such as FDA 21 CFR Part 11 and GAMP 5, and ensure that computer systems align with these standards
- Review and approve project related documents for l GxP relevant systems
Sr.Manager
Makrocare
Hyderabad
01.2019 - 03.2024
- As Associate Director from Apr 2022, managed Gxp IT applications compliance with regulatory requirements.
- Author, Review and approve CSV documentation.
- Involve in investigations and CAPA related to IT applications
- QMS implementation in Drug Development Informatics (DDi, functional partner of Makrocare)
- Responsible for overall implementation of Quality Management system in line with ISO 9001, ISO 13485
- Ensure regulatory compliance of GxP systems by the application industry standard regulations, such as FDA 21 CFR Part 11 and GAMP 5, and ensure that computer systems align with these standards
- Experience on applications like EDC, IRT, CDMS etc
- Implement security policies and procedures across the organization.
- Review of in-house validation deliverables for softwares used and infrastructure qualification documents
- Periodic review of computerized systems
- Review of Vendor provided Validation packages to check the adequacy and URS
- Risk Management in clinical trials and project risk management
- Perform and deliver quality audits/audit reports within specified timelines.
- Review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
- Provide training to new auditors by performing co-audits, delivering training, and sharing knowledge and experience
QA Validation Team Lead
Exela Pharma Sciences
North Carolina
05.2016 - 10.2018
- Review of Equipment Qualification (IQ, OQ & PQ) and annual Maintenance Validation Reports
- Serve as a subject matter expert, and provide mentorship, leadership, and guidance in Validation activities
- Review of completed Manufacturing Batch Production Records
- Review of Process Performance Qualification Reports
- Review of deviations, change controls, OOS, Complaints, etc
Group Leader QA (GCP & GMP, ISO17025)
Vimta Labs Ltd
Hyderabad
01.2012 - 04.2016
- Responsible for the overall implementation of the Quality Management system in the laboratory complying with GMP requirements and ICH GCP
- Responsible for activities of the Quality Assurance Department to ensure compliance with company, customer, and regulatory requirements
- Involve/Author the responses to regulatory queries for the US FDA, WHO, and MHRA
- Conduct Internal Quality audits and process audits, safety audits in various divisions/departments in the company
- Review of Calibrations, Equipment Qualifications, Software qualifications, and Computer system validations and Validation reports, Infrastructure qualification documents
Clinical Quality Auditor
Vimta Labs Ltd
Hyderabad
07.2006 - 08.2012
- Assist in the management and implementation of the Quality Management System in the Clinical Research Division
- Review of study protocols, ICFs, CRF, TMFs, study-related raw data, and final summary report of BA/BE studies
- Review of Method validations, bioanalytical reports, statistical reports, Clinical study reports, and eCTD submission modules
- Conduct study audits for BA/BE studies
- Conduct Internal Quality audits and process audits in various divisions/departments in the company to verify compliance with quality systems, SOPs, protocols, applicable guidelines, and regulatory and customer requirements
Education
Master - Pharmaceutical Analysis
Osmania University
Hyderabad, Telangana, India01.2022
Bachelor - Pharmacy
Osmania University
Hyderabad, Telangana, India04.2005
Skills
- Strategic Decision Making
- Effective Leadership
- Strategic Issue Resolution
- Effective Team Collaboration
- Individual contribution
- Time Management
- Conflict Resolution
- Attention to detail
- Flexible Attitude
- Clear communication
- Vendor management
Accomplishments
- Global clinical study audits/Singapore facility on-site audit in April 2023 as per HBRA regulation, ICH GCP, and ISO 13485 for device studies.
- Global clinical study audits/Remote Clinical study and system audits of US clients in Sep and October 2022.
- Faced regulatory inspections WHO, MHRA, USFDA, CDSCO, DCGI, and DCA inspections as designee to Quality Manager and prime member of war room.
- Acted as Scribe for US FDA inspection in 2014.
- Excelled as Quality Assurance -Team Lead for Vimta Labs Ltd, awarded for the year 2014.
Training
- CISA course
- Professional diploma in Project Management
- ISO 9001
- ISO 13485
- ISO 14155
- MDR and IVDR regulations
- HIPPA-GDPR regulations
- ICH GCP
- ISO 17025: 2005
- Risk Management
- GMP training
- Internal Auditor Training course - GLP
- Software Validation - FDA perspective
Timeline
Manager ITN Audit and CAPA
Qinecsa Solutions
03.2024 - Current
Sr.Manager
Makrocare
01.2019 - 03.2024
QA Validation Team Lead
Exela Pharma Sciences
05.2016 - 10.2018
Group Leader QA (GCP & GMP, ISO17025)
Vimta Labs Ltd
01.2012 - 04.2016
Clinical Quality Auditor
Vimta Labs Ltd
07.2006 - 08.2012
Master - Pharmaceutical Analysis
Osmania University
Bachelor - Pharmacy
Osmania University
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