Product Manager - Quality Solutions

Qualification: B.Tech +MBA preferred Experience: 5+ years in pharma manufacturing and quality in consulting firm ​ Hands on experience in implementing, managing and building Digital Quality Solutions (ex: LIMS, Empower, LMS, etc.) in Pharmaceutical industry Interact with the business to understand business requirements and document the project scope including conceptual design solutions. Map business processes and propose recommendations for process automation and optimization wherever applicable. Interact with the quality team for the transformation of the current manual operations to digital by using latest technologies. Responsible for executing tasks and producing deliverables as outlined in the Project plan. Responsible to coordinate and support for project phase activities at rollout sites as per defined in rollout validation plan. Responsible for contributing to overall project objectives and specific deliverables. Responsible for review of validation documents. Responsible for preparation and review of risk assessment and control activities. Work with architects and business partners to identify technical solutions and business process improvements that are in line with IT and business needs. Interact with end users and solution provider to develop system design specification and functional specifications wherever applicable. Identify, track, manage and mitigate project risks / issues, manage scope and for change follow change management process. Work with business partners, internal team to work on any hardware / software procurement as per the project resources. Preparation of relevant SOP’s and coordinate with respective department to revise the SOP if required. Analyzing the system issue in Quality Solutions (LIMS, Empower, LMS, etc.) applications to escalate with business partners and get it resolved along with necessary documentation review. Ensuring the compliance to procedures for all the activities in GxP relevant systems. Acting as SME for technical aspects related to functionalities for Quality Management applications. Responsible to analyzing the issue and query raised by end user or any system bug observed in running application. Responsible for review and confirmation of release note send by vendor for any issues or requirements. Responsible to support for evaluation, verification and testing of any patch updated in the application. Responsible for training to the concern team members related to Quality Applications (ex: LIMS, Empower, LMS, etc.) application and relevant SOP’s. Responsible for testing, followed by operational qualification for application changes. Responsible for active participation in executing validation activities such as IQ, SAT and UAT at rollout sites. Responsible to support for Master Creation. Responsible for the support of application during inspections, Internal & External Audits. Overall project deliverable – scoping, project planning, requirements document, proposal and other requisite documents. Identify, track, manage and mitigate project risks / issues, manage scope and for change follow change management process. Responsible to plan, execute and coordinate for the user trainings. System Administration for the respective applications for the User Account Management, System Maintenance and System Upgrades. Application health / performance check as per the recommendations from the business partners. Responsible to execute any other work assigned by reporting manager / HOD as per the need in the assigned role.