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. LIMS (Laboratory Information Management System), Empower, GXP, CSV, Data Analytics, Robotic Process Automation

• Product Quality Engineer

  Birla Pivot · Bangalore Urban, Karnataka, India