Prabhakar J Email & Phone Number
Who is Prabhakar J? Overview
A concise factual answer block for searchers comparing this professional profile.
Prabhakar J is listed as Business Partner at Pharma Digital solutions startup, based in Hyderabad, Telangana, India. AeroLeads shows a matched LinkedIn profile for Prabhakar J.
Prabhakar J previously worked as Digital Transformation and Process Excellence at Dr. Reddy'S Laboratories and Senior Manager - IT Quality & CSV at Biocon Limited. Prabhakar J holds Master'S Degree, Information Technology from Acharya Nagarjuna University.
About Prabhakar J
Digital Transformation Professional with over 20+ years of extensive experience in quality processes, IT Quality, and Computerized Systems Validation (CSV) within the pharmaceutical sector, I bring a deep expertise in developing and implementing Quality Assurance Strategies and Policies. Additionally, I have a strong background in managing all aspects of the IT Service Life Cycle, ensuring alignment with industry standards and best practices. My areas of expertise include:o Quality Process Design: Spearheaded the design and development of Quality processes for the Software Development Life Cycle (SDLC) and Computer System Validation, ensuring compliance with industry standards.o Quality Oversight: Led the IT Quality function to ensure that all operational activities of GxP systems, including changes, periodic reviews, and deviations, are fully compliant with organizational policies and regulatory standards.o Application Development: Extensive experience in developing a wide range of pharmaceutical applications, including Quality Management Systems, Document Management Systems, Warehouse Management Systems, and eLog Management. Additionally, I have been actively involved in the development of applications leveraging Generative AI and various Large Language Models (LLMs), which are increasingly essential in the pharmaceutical industry. Approach centers on design thinking, ensuring that these solutions are both practical and aligned with user needs and industry standards.o Product Management: Successfully acted as a product manager for various GxP systems, delivering innovative solutions to businesses through the adoption of Agile Methodologies.o Global Rollouts: Experienced in Global Application rollouts, ensuring Lifecycle Management adheres to policies, SOPs, and procedureso Lifecycle Management: Responsible for end-to-end Lifecycle Management of GxP applications, ensuring compliance with relevant guidelines and regulations such as GAMP, 21 CFR Part 11, EU Annex 11 etc.o Audit Management: Led over 100+ regulatory and customer audits, including USFDA (15), MHRA (7), TGA (5), ANVISA (5), WHO, CDSCO (8), and 75 customer audits, focusing on Quality Systems, IT Systems, validations, and documentation controls.o Business Analytics: Designed and developed quality analytics and dashboards to track business KPIs, leveraging data for predictive and prescriptive analytics.o Leadership Skills: An effective team leader with a proven ability to initiate and manage cross-functional teams and multidisciplinary projects.
Prabhakar J's current company
Company context helps verify the profile and gives searchers a useful next step.
Prabhakar J work experience
A career timeline built from the work history available for this profile.
Digital Transformation And Process Excellence
o Spearhead the development, implementation, and continuous improvement of robust Quality Management Systems (QMS) across the organization, ensuring compliance with industry regulations and best practices. o Drive the alignment of QMS with corporate goals, fostering a culture of quality and excellence throughout all operations.o Lead the Digital Transformation initiatives within the Quality function, including the modernization of QMS and other innovative quality projects. Leverage… Show more o Spearhead the development, implementation, and continuous improvement of robust Quality Management Systems (QMS) across the organization, ensuring compliance with industry regulations and best practices. o Drive the alignment of QMS with corporate goals, fostering a culture of quality and excellence throughout all operations.o Lead the Digital Transformation initiatives within the Quality function, including the modernization of QMS and other innovative quality projects. Leverage advanced technologies to enhance process efficiency, data accuracy, and overall quality outcomes.o Oversee the design and development of advanced business analytics solutions using data from the Manufacturing Quality Data Lake (MQDL) hosted on Google Cloud Platform (GCP). Ensured that the solutions are scalable, reliable, and capable of delivering actionable insights to support data-driven decision-making.o Responsible for tracking of key business performance indicators (KPIs) through interactive dashboards. Apply artificial intelligence and machine learning (AI/ML) technologies to analyze data, uncover trends, and generate insights that drive strategic decisions and continuous improvement initiatives. Show less
Senior Manager - It Quality & Csv
o Led IT Quality and Computerized Systems Validation (CSV) vertical within the Corporate Quality Assurance function to develop and implement IT Quality standards and validation processes, ensuring compliance with regulatory requirements and industry best practices.o Acted as the single point of contact for all digital initiatives by alignment with the organization's strategic objectives and maintaining high standards of quality and compliance.o Developed comprehensive policies and… Show more o Led IT Quality and Computerized Systems Validation (CSV) vertical within the Corporate Quality Assurance function to develop and implement IT Quality standards and validation processes, ensuring compliance with regulatory requirements and industry best practices.o Acted as the single point of contact for all digital initiatives by alignment with the organization's strategic objectives and maintaining high standards of quality and compliance.o Developed comprehensive policies and procedures that governed the use of digital systems across the organization, ensuring consistency, compliance, and operational excellence on a global scale. Show less
Senior Manager - It Quality & Csv
o Lead the IT Quality and CSV functiono Lead the validation of computerized systems, ensuring compliance with regulatory standards.o Manage and oversee application testing to ensure system functionality and reliability.o Coordinate and drive project management efforts, ensuring successful project delivery.o Act as a Subject Matter Expert (SME) in application design and development.o Provide expert guidance to ensure adherence to best practices and project objectives.
Manager Itqa
Manager (role band R2B) – ITQA (GQM Function) – From 2017 to 2018 Manager (role band R2A) – ITQA (Unit 3 Quality Function) – From 2014 to 2016 Asst. Manager – ITQA and Documentation (Unit 3, Quality Function) – From 2009 to 2013Junior Manager – Documentation Assurance (Unit 3, Quality Function) – From 2006 to 2009o Handled different roles in Quality Function like Documentation Assurance, ITQA and Engineering Assurance from 2006 to 2018.o The specific ITQA role was… Show more Manager (role band R2B) – ITQA (GQM Function) – From 2017 to 2018 Manager (role band R2A) – ITQA (Unit 3 Quality Function) – From 2014 to 2016 Asst. Manager – ITQA and Documentation (Unit 3, Quality Function) – From 2009 to 2013Junior Manager – Documentation Assurance (Unit 3, Quality Function) – From 2006 to 2009o Handled different roles in Quality Function like Documentation Assurance, ITQA and Engineering Assurance from 2006 to 2018.o The specific ITQA role was created and led to design and implement the Quality Notifications using SAP QM module.o Played a key role in designing and rolling out the QMS processes across Dr. Reddy’s (initial step to switch from paper to digital)o Between 2009 and 2018, the role increased progressively to include the implementation of the following systems across all sites of Dr. Reddy’s sites not only in India but also in USA, EU and Germany. SAP – Quality Management System (QMS) Learning management System (LMS) Laboratory Information Management System (LIMS) Document Management System (DMS) Manufacturing Execution System (MES) Serialization for finished goods (e-Pedigree) Warehouse Management System (WMS) Multiple Empower upgrades Data Integrity and Data Governance assessment and remediation for all laboratory and manufacturing systems Finished Goods Auto conveying system Building Management System (BMS) Environment Management System (EMS) Data Acquisition System (DAS) Data Analytics and Dashboardo Lead the regulatory and customer audits w.r.t IT applications; Inclusive of identification of appropriate CAPAs for audit observations and implementing the same across Business Unitso Identification, evaluation and implementation of suitable digital solutiono Conduced multiple supplier audits for GxP application providers o SME for review and approval of change controls related to all GxP IT applicationso Develop procedures and Policies for GxP applications Show less
Warehouse Assistant
o Responsible for handling of GRN’s for the inward materialso Responsible for issuance and reconciliation of materialso Ensure and track the inventory and send the weekly report to Head Warehouse
Team Lead
o Scanning of documentso Proofreading of content from the scanned documento Consolidation of final contento Submission of content to customer
Prabhakar J education
Master'S Degree, Information Technology
Master'S Degree, Information Technology
Frequently asked questions about Prabhakar J
Quick answers generated from the profile data available on this page.
What company does Prabhakar J work for?
Prabhakar J works for Pharma Digital solutions startup.
What is Prabhakar J's role at Pharma Digital solutions startup?
Prabhakar J is listed as Business Partner at Pharma Digital solutions startup.
Where is Prabhakar J based?
Prabhakar J is based in Hyderabad, Telangana, India while working with Pharma Digital solutions startup.
What companies has Prabhakar J worked for?
Prabhakar J has worked for Pharma Digital Solutions Startup, Dr. Reddy'S Laboratories, Biocon Limited, Audree Infotech Pvt. Ltd, and Nucon Industres Pvt Ltd.
How can I contact Prabhakar J?
You can use AeroLeads to view verified contact signals for Prabhakar J at Pharma Digital solutions startup, including work email, phone, and LinkedIn data when available.
What schools did Prabhakar J attend?
Prabhakar J holds Master'S Degree, Information Technology from Acharya Nagarjuna University.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trialCheck these profiles if this is not the Prabhakar J you were looking for.
View similar profiles