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.
