Abhinay Jilukara
Summary
Experience working with GxP’s like Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Good Documentation Practice (GDP) and Good Clinical Practices (GCP) suites. Good knowledge of International Standards as well as Federal (US) Regulations21 CFR part 11, compliances. Extensive Experience with GAMP 5 guidelines, User Requirement Specifications, Functional Requirements, Installation Qualification (IQs), Operational Qualification (OQs) and Performance Qualification (PQs) with a variety of commercial off-the-shelf systems. Expertise with Corrective Action and Preventive Action (CAPA) investigation to identify and evaluate the problem or non-conformance. Diversified experience on both Manual and Automation testing with thorough knowledge of Computer System Validation Life Cycle and Software Development Life Cycle (SDLC). Experience with applications such as Laboratory Information Management System (LIMS), Electronic Data Management System (EDMS), Electronic Data Capture (EDC). Good working knowledge in 21 CFR Part 11, ICH, EMEA, and GxP regulations.
Overview
6
6
years of professional experience
Work History
SDLC Quality Engineer
Standard Groups
10.2022 - 08.2023
- Worked on Both GxP & Non-GxP systems life cycle.
- Participated and undertook training for System Development Life Cycle (SDLC), SDLC Compliance Review, Approvals, Validation Practitioner and applicable GxP training.
- Practitioner training completed and reviewed with references to the related Policies, Guidelines and SOPs including project deliverables.
- Review the SIT/UAT test cases and conduct pre and post approvals of the test cases.
- Conducted Quality Gate Assessments at the end of each life cycle phase.
- Review/Approve the Change Requests in accordance with Merck IT procedures.
- Authored/Support authoring of SDLC documents (Assessments, QAP, QASR, Test Plans, Test Summaries, UAT Test Plan, Requirements/Configuration).
- Author remediation to support corrective/preventative measures for internal assessments.
Validation Engineer
Honor Pvt Ltd
12.2019 - 10.2022
- Worked on the validation of LIMS system, which provides inventory management, sample storage, sample ordering for performing analytical laboratory testing, chain of custody for samples, importing and transferring of analytical results.
- Interacted with the Business Users and the Business Sponsor to gather the system User Requirements and the Functional Requirements.
- Interacted with the Developers and Subject Matter Experts (SME) to better understand the workflow and functionalities on different modules.
- Responsible for validating the reports generated by the LIMS application are in compliance with 21 CFR part 11 and Good Laboratory Practices.
- Performed Part 11 and GMP Assessment to define the regulations required for the system.
- Responsible for authoring and reviewing documentation for all phases of the computer systems validation lifecycle in accordance with cGxP Standards, FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) for LIMS software.
- Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.
- Authored OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
- Involved in reviewing Corrective Action and Preventive Action (CAPA) and corresponding change control procedures and drafted Remediation plans for the project after GAP analysis.
Operations Excellence Process Engineer
Granules India Pvt Ltd
09.2017 - 12.2019
- Preparing the costing for the new projects.
- Worked closely with onsite PMO office regarding the deliverables and project timelines.
- Involved in all the work streams activities and developed IQ/OQ/PQ scripts.
- Planning the new projects for execution with targeted timelines.
- Transferring Technology from lab scale to kilo lab then kilo lab to plant scale.
- Preparing Process Flow Diagrams and P&IDs.
- Coordinating with other departments like R&D, Production and QA, QC etc... For the successful scale-up within the targeted timelines.
- Following batches for validation as per the cGMP and taking care to maintain the process parameters.
- Preparation of scale-up documents for execution of batches in the plant.
- Providing the equipment mapping according to the process flow.
- Preparing the timelines for the new RFPs (Request for proposals).
- Providing the costing according to the process flow.
Education
Master’s - Business Analytics
Saint Peter’s University
02.2025
Bachelor of Technology - Chemical Engineering
National Institute of Technology
Agartala, India05.2017
Skills
- Project Management
- Supply Chain Management
- Product Development
- Business Development
- Vendor Management
- Procurement
- Process Improvement
- Computer System Validations
- MS Excel
- Validation Deliverables
- 21 CFR Part 11
- 210-211
- 803
- 820
- Annex 11
- GAMP
- Audit Trails
- Standard Operating Procedures (SOPs)
Timeline
SDLC Quality Engineer
Standard Groups
10.2022 - 08.2023
Validation Engineer
Honor Pvt Ltd
12.2019 - 10.2022
Operations Excellence Process Engineer
Granules India Pvt Ltd
09.2017 - 12.2019
Master’s - Business Analytics
Saint Peter’s University
Bachelor of Technology - Chemical Engineering
National Institute of Technology
Similar Profiles
AMOS ODUROAMOS ODURO
Assistant manager at OAK-VAN GROUPS OF COMPANIES (PROCUREMENT&SUPPLY)Assistant manager at OAK-VAN GROUPS OF COMPANIES (PROCUREMENT&SUPPLY)
Saranya KrishnanSaranya Krishnan
Administrative officer cum Accountant at S.V Groups of CompaniesAdministrative officer cum Accountant at S.V Groups of Companies
Sumit Tukaram PatilSumit Tukaram Patil
Assistant Manager - Ticketing at Hind Musafir Agency of Bajaj GroupsAssistant Manager - Ticketing at Hind Musafir Agency of Bajaj Groups
Prashant KumarPrashant Kumar
<ul><li>Roles and Responsibilities</li><li>Hiring and team building</li><li>Managing team’s career progression and performance reviews</li><li>Managing Performance improvement plan and firing</li><li>Mentoring</li><li>Product roadmap planning and execution</li><li>Accountability of the entire delivery execution including the risk mitigation planning.</li><li>Stakeholder management</li><li>Adhering to Apple Privacy and Security Guidelines for platform</li><li>Design and implementation of new architectures and solutions to manage all online services for AdXchange in Apple Ads.</li><li>Design and implementation of new architectures and solutions deliver Budget experimentation in Apple Ads</li><li>Design and implementation of new architectures and solutions to manage data for Ad Platform.</li><li>Creating and maintaining all the data and analytics and revenue pipelines for Ad Platforms</li><li>Driving the solution for data ingestions and data processing across Ad platform</li><li>Defining the Strategy for data governance and data access</li><li>Collaboration with business to deliver relevant data and insight for our strategy and decisions.</li><li>Managing storage, processing, copy/synchronization etc. appropriate to scale</li><li>Enabling machine learning and algorithm groups by proving them right frameworks and data</li><li>Advancing team’s design methodology and quality programming practices and evangelize those techniques across Ad platform.</li><li>Deliveries</li><li>Setup 8+ member team to design and deliver Budget Allocation and Budget experimentation.</li><li>Leading Ad Delivery services team, responsible for delivering various capabilities like query understanding, targeting, fraud etc.</li><li>Delivered and Lead Design for observability for budget, and data platform in Ad platform.</li><li>Setup 11+ members high performing team to handle various business needs such as analytics and micro services for Display Advertising as well as Data Platform</li><li>Instrumental in driving Data Platform throughout the SDLC from inception, design, development, testing and deployment.</li><li>Instilled a strong team culture of high-quality delivery by constructive feedback, cross collaboration, focus and motivation.</li><li>Delivered Realtime and Batch Platform with various integrations</li><li>Delivered new DIP design for Data Platform</li><li>Delivered design of all the components of Data processing platform</li><li>Transitioned Display data work to India seamlessly and delivered many critical business impacting features and organizational security initiatives.</li><li>Closely worked with various stakeholders to understand the requirements which resulted into efficient remote work culture.</li><li>Seamless Display execution and set up best practices for 24X7 production on-call.</li><li>Tools and Technologies</li><li>AWS, S3, Kafka, Spark, Hadoop, EMR, Hive, Scoop, Flume, Cassandra, Airflow, Oozie, Gobblin, Schema Store, Icloud, Grafana, Kubernetes, Vertica, Alation, snowflake, druid, Iceberg, Java, Scala, IntelliJ, Oracle, MySql, Git, RIO, Spinnaker, Elastic cache, Grpc, Agile.</li></ul> at Apple - Adplatform<ul><li>Roles and Responsibilities</li><li>Hiring and team building</li><li>Managing team’s career progression and performance reviews</li><li>Managing Performance improvement plan and firing</li><li>Mentoring</li><li>Product roadmap planning and execution</li><li>Accountability of the entire delivery execution including the risk mitigation planning.</li><li>Stakeholder management</li><li>Adhering to Apple Privacy and Security Guidelines for platform</li><li>Design and implementation of new architectures and solutions to manage all online services for AdXchange in Apple Ads.</li><li>Design and implementation of new architectures and solutions deliver Budget experimentation in Apple Ads</li><li>Design and implementation of new architectures and solutions to manage data for Ad Platform.</li><li>Creating and maintaining all the data and analytics and revenue pipelines for Ad Platforms</li><li>Driving the solution for data ingestions and data processing across Ad platform</li><li>Defining the Strategy for data governance and data access</li><li>Collaboration with business to deliver relevant data and insight for our strategy and decisions.</li><li>Managing storage, processing, copy/synchronization etc. appropriate to scale</li><li>Enabling machine learning and algorithm groups by proving them right frameworks and data</li><li>Advancing team’s design methodology and quality programming practices and evangelize those techniques across Ad platform.</li><li>Deliveries</li><li>Setup 8+ member team to design and deliver Budget Allocation and Budget experimentation.</li><li>Leading Ad Delivery services team, responsible for delivering various capabilities like query understanding, targeting, fraud etc.</li><li>Delivered and Lead Design for observability for budget, and data platform in Ad platform.</li><li>Setup 11+ members high performing team to handle various business needs such as analytics and micro services for Display Advertising as well as Data Platform</li><li>Instrumental in driving Data Platform throughout the SDLC from inception, design, development, testing and deployment.</li><li>Instilled a strong team culture of high-quality delivery by constructive feedback, cross collaboration, focus and motivation.</li><li>Delivered Realtime and Batch Platform with various integrations</li><li>Delivered new DIP design for Data Platform</li><li>Delivered design of all the components of Data processing platform</li><li>Transitioned Display data work to India seamlessly and delivered many critical business impacting features and organizational security initiatives.</li><li>Closely worked with various stakeholders to understand the requirements which resulted into efficient remote work culture.</li><li>Seamless Display execution and set up best practices for 24X7 production on-call.</li><li>Tools and Technologies</li><li>AWS, S3, Kafka, Spark, Hadoop, EMR, Hive, Scoop, Flume, Cassandra, Airflow, Oozie, Gobblin, Schema Store, Icloud, Grafana, Kubernetes, Vertica, Alation, snowflake, druid, Iceberg, Java, Scala, IntelliJ, Oracle, MySql, Git, RIO, Spinnaker, Elastic cache, Grpc, Agile.</li></ul> at Apple - Adplatform
Atish RaneAtish Rane
<ul> <li>Leading a team of 10 software developers through the complete SDLC — from requirement gathering, design, development, code reviews, testing, to deployment.</li> <li>Designed and developed robust Java-based applications using Spring Boot, Hibernate, JSP, and REST APIs.</li> <li>Acted as the primary point of contact between business stakeholders and the technical team to ensure clear communication and successful delivery.</li> <li>Oversaw sprint planning, task assignments, and status tracking using Agile methodologies (Scrum).</li> <li>Reviewed code and ensured adherence to best practices, improving overall code quality and maintainability.</li> <li>Delivered multiple high-impact projects on time, meeting all performance and scalability requirements.</li> <li>Provided mentorship and technical guidance to junior developers, improving team efficiency and knowledge sharing.</li> </ul> at Mobicule Technology pvt.ltd<ul> <li>Leading a team of 10 software developers through the complete SDLC — from requirement gathering, design, development, code reviews, testing, to deployment.</li> <li>Designed and developed robust Java-based applications using Spring Boot, Hibernate, JSP, and REST APIs.</li> <li>Acted as the primary point of contact between business stakeholders and the technical team to ensure clear communication and successful delivery.</li> <li>Oversaw sprint planning, task assignments, and status tracking using Agile methodologies (Scrum).</li> <li>Reviewed code and ensured adherence to best practices, improving overall code quality and maintainability.</li> <li>Delivered multiple high-impact projects on time, meeting all performance and scalability requirements.</li> <li>Provided mentorship and technical guidance to junior developers, improving team efficiency and knowledge sharing.</li> </ul> at Mobicule Technology pvt.ltd