Aurigene - Product Manager (6-8 yrs)

Product Manager

Responsibilities:

- 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