Job Description:
· The project engineer will be responsible to drive product development team which is working on a product for Clinical IT data migration in the Life Sciences industry.
· The project engineer will prepare and maintain project plan for the product milestones in a multi-year product development initiative.
· Responsible for maintaining the standards for the product delivery using Quality Management System, Document Management System, and GxP Validation techniques like Change Control, Deviation Management, CAPA, Root Cause Analysis, and Non-Conformance reports.
· Responsible for leading the development and maintenance of GxP Validation documents as per FDA regulation 21 CFR Part 11 and 21 CFR Part 820. These documents may include Validation Plans, Risk Assessments, Requirement Specification, IQ/OQ/PQ Protocols, Trace Matrix, Test Execution Reports, and Summary Reports.
· Responsible for the coordination of Change Controls (CRs), Failure Investigations, and CAPA in the GxP environment.
· Responsible for communication with Technical team, Business team, Validation team and developers for ensuring the adherence to the Quality Policy, Quality Manuals and Standard Operating Procedures (SOPs).
· Responsible for resolving day today technical issues.
· Responsible for Monitoring on-going compliance and perform periodic IT system reviews ensuring that the systems are maintained in a validated state.
· Providing technical and investigational support in troubleshooting and resolving manufacturing process or IT system issues.
· Working with Subject Matter Experts and System Owners to gather information and investigate issues for creating CAPA Records and driving CAPAs to closure.
· Active participation in weekly cross-functional meetings and interface with all internal departments working on projects to keep up to date on project status and ensure timely completion by maintaining a list of all open actions.
· Interaction with Quality management members to identify compliance gaps within the product development modules and find effective solutions.
· Implement Waterfall as well as Agile methodologies for the project execution using Sprint/Kanban boards in JIRA or similar project management platforms.
Qualifications:
· Masters in Engineering with specialization in project management, quality management and continuous improvement.
· Six Sigma Green Belt Certified.
· Experience in leading GxP Validation of IT Systems for Life Sciences companies.
· Working Knowledge of cGMP and GDP preferred. Must be able to produce GxP validation documentation.
· Process development/project management experience required.
· Knowledge of Software validation process, manufacturing processes, automation techniques, and testing methodologies.
· Experience in leading and assisting in investigative activities, completion of CAPAs, SOPs, Change Controls, and other related quality compliance activities.
· Knowledge of 21 CFR Part 11 compliance for the IT Systems in GxP environment.
· Experience in leading IT quality assurance initiatives. Detailed understanding of Quality Management Systems (QMS), and IT regulatory compliance.
· Knowledgeable in document management and quality management systems.
Soft skills:
· Strong communication and presentation skills.
· Ability to multi-task effectively.
· Strong writing skills.
· Ability to work independently with minimal supervision.
· Flexibility to participate in global virtual meetings outside of normal business hours.
Success is result of the work we put together as a Team. Together we work hard, brainstorm, learn and explore.
We provide services to make business run smother and efficient.
We are looking for self motivated people who are passionate and want to build a career in data science.
Waiting to hear from you, contact us at hr@aaconsultancyus.com.
· The Veeva Vault Developer will work as part of our product development team which is working on developing a custom product for Clinical IT data migration in the Life Sciences industry.
Job Description:
· Work with senior members of the team to analyze product requirements, translating those requirements into customizable product features.
· Develop product features like API interfaces and connectors to Veeva Vaults.
· Develop Veeva customization modules of the product.
· Lead development work streams, from design through testing and deployment, often working with junior members of the team spread across different geographical locations.
· Work with project leadership, assist in the estimation of work effort, determination of required resources, and set a realistic schedule for development.
· Ensure on time code delivery and relevant information with the ability to quickly identify and report project risks.
· Perform Unit Testing and Integration testing of product modules.
· Prepare quality processes, quality documents, test scripts, and quality artifacts in an agile product development environment.
· Participate and contribute to agile scrum activities.
· Assist client teams in supporting the live application and perform handoff, knowledge transfer, and client support activities for software our product.
· Active participation in weekly cross-functional meetings and interface with all internal departments working on projects to keep up to date on project status and ensure timely completion by maintaining a list of all open actions.
· Interaction with Quality management members to identify compliance gaps within the product development modules and find effective solutions.
· Implement Waterfall as well as Agile methodologies for the project execution using Sprint/Kanban boards in JIRA or similar project management platforms.
Qualifications:
· Masters in Computer Science or equivalent degree.
· Veeva Vault Platform White Belt Certification is a must.
· Expertise in Veeva QMS and QualityDocs Vaults. Experience in document management and quality management systems.
· Scrum Product, Scrum
· Experience in GxP Validation of IT Systems for Life Sciences companies.
· Must be able to produce GxP validation documentation.
· Process development/project management experience required.
· Knowledge of 21 CFR Part 11 compliance for the IT Systems in GxP environment.
· Experience in leading IT quality assurance initiatives. Detailed understanding of Quality Management Systems (QMS), and IT regulatory compliance.
Soft skills:
· Strong communication and presentation skills.
· Ability to multi-task effectively.
· Strong writing skills.
· Ability to work independently with minimal supervision.
· Flexibility to participate in global virtual meetings outside of normal business hours.