Product Manager - Quality Solutions

As a qualified candidate for this position, you should ideally hold a B.Tech degree, and an MBA qualification would be considered advantageous. With at least 5 years of experience in pharma manufacturing and quality, specifically in a consulting firm, you have gained valuable insights and expertise in the industry. Your primary responsibilities will revolve around implementing, managing, and developing Digital Quality Solutions within the pharmaceutical sector. This includes hands-on experience with various tools such as LIMS, Empower, and LMS. You will be expected to collaborate closely with the business stakeholders to grasp their requirements and effectively document project scopes, including conceptual design solutions. One of your key roles will involve mapping out existing business processes and offering recommendations for automation and optimization wherever feasible. You will work closely with the quality team to transition manual operations to digital platforms using the latest technologies available. Your tasks will encompass executing project plans, coordinating activities during project phases, contributing to project objectives, and reviewing validation documents. Additionally, you will be responsible for risk assessment, control activities, and ensuring compliance with GxP relevant systems. Collaboration with architects and business partners to identify technical solutions and process improvements aligned with both IT and business needs will be crucial. You will also engage with end users and solution providers to develop system design specifications and functional requirements as needed. Throughout the project lifecycle, you will need to identify, track, manage, and mitigate risks and issues, following the change management process diligently. Your role will also involve working on hardware/software procurement, preparing SOPs, and coordinating with various departments for revisions. Furthermore, you will act as a subject matter expert for technical functionalities related to Quality Management applications. You will handle system issues, escalate concerns with business partners, ensure compliance with procedures, and support evaluation, verification, and testing of application patches. Training team members, conducting system health checks, supporting application during inspections and audits, and fulfilling any other assigned tasks will also be part of your responsibilities. Your role will play a critical part in scoping project deliverables, planning, documentation, user training, system administration, and application maintenance. In summary, your role will be dynamic and multifaceted, requiring strong technical expertise, project management skills, and a proactive approach to effectively drive digital quality initiatives within the pharmaceutical industry.,