Job Title:  Executive - Portfolio Program

Qualification: Graduate / Post Graduate in Pharmacy with 3-6 years of experience in Pharmaceutical Quality Assurance or Production

• Candidate having sound experience in documentation as well as execution of oral solid dosage Production process starting from Dispensing to Secondary packing.
• 3-6 years of exposure either in Quality Assurance (IPQA, QMS) or Manufacturing/Production section including Manufacturing or packing section

Specific Requirements:

• Experience in IPQA, QMS or Production activities of Solid Dosage Form (Tablets).
• Worked with EU regulatory-approved pants.
• Quality assurance (IPQA, QMS)
• Operating SAP/ERP and QMS tools (Trackwise, Quality forward)
• Compilation and Documentation of Pharmaceutical documents
• Communication, coordination, Tracking and Exposure to Shop floor

Job Summary:

Key member of Portfolio Program function in Site Strategy Execution team. Executive / Sr. Executive – Portfolio Project Management is primarily responsible to support Portfolio Program Manager for successful Planning and execution by ensuring end-to-end tracking and coordination of project activities identified for ongoing / new projects such as Product Transfer, New Development, Product supply switch, New product launch and alternate source implementation in line with Zentiva roadmap to deliver ‘on time in full’ commitments from LRP and budget by engaging relevant functions and operations in the organization.

The role will be as well accountable to sustain overall Execution, Tracking and Coordination system (reporting and governance) established as a common way of working and measure across the various functions and sites involved.

All above activities shall be performed in line with Zentiva’s compliance requirement (Quality and Safety).

• Strong communication and coordination skills within the team and cross-functional departments
• Process knowledge and awareness with Quality/QMS tools
• Knowledge of SAP and QMS tools (eDMS, Trackwise, Quality Forward)
• Compilation and documentation of Pharmaceutical documentation
• Management of Shopfloor associated activities
• Stakeholder Management

KEY ACCOUNTABILITIES

Process

• Responsible to support Perform Program Manager by ensuring end-to-end tracking and coordination of Product Transfer, New Development, Supply switch, Launch and alternate supplier implementation activities for the site, to achieve timely project completion which can support growth..
• Understand the tech transfer of new products from Development scale to commercial production.
• Experience to Prepare, Review, and Execute Technology Transfer Protocols, MFRs, BMRs, and Validation Protocols / Reports.
• Experience to Execute the validation / registration batches at Shop floor
• Fundamental understanding about Product scale up and associated complexities and its management
• Management of all identified project actions at site using project plan and to check their accomplishment for successful project execution.
• Participation and engagement with site as well as global project team beginning from Product feasibility, Technology transfer till launch/supply switch for the new development/internalize transfer products and alternate source implementation identified for the products concerned.
• Understanding communication of relevant information associated to projects received from the Development / Portfolio team to other cross functional team members of the technical team.
• Engaging project team members through regular calls and steering regular project team meetings across the respective organizational group.
• Responsible to Cooperates with site as well as external stakeholders, transfer team (both global and site) for identified projects, i.e. Product Transfer, New Development, COGs optimization and capacity utilization, Alternate supplier implementation, Product life cycle management and process optimization.
• Participating and actively managing regular, cross-functional Launch Management meetings, to ensure timely delivery of work packages of all involved stakeholders
• Effective and successful communication with all stakeholders
• Support continuous improvement activities by participating in cost engineering techniques and operational excellence techniques, identifying inefficiencies and cost optimisation opportunities.
• Other activities priority assigned by Portfolio Program Manager.

Compliance

• Adherence to Zentiva Quality, HSE and organizational compliance
• Ensure timely completion of training in order to comply with Quality and HSE compliance across all levels
• Capture good practices across the organization (techniques, processes, management etc..)
• Share good practices across the organization
• Feedback to process / function owners the new standards requirement for future development of processes / products

Monitoring and Improvement:

• Provides project updates and reports on project progress to both site as well as global management using Process flow Tracker or suitable project tracker established.
• Coordinating with Shop floor team members for Transfer project / source change related activities on the shop floor in production areas.
• Coordination and Follow-up with cross functional project team including Production, Quality, Warehouse – Supply chain, Procurement and Controlling according to the action items defined and maintain current status in the tracker.
• Preparation and timely revision of project-related documentation and databases, e.g. Product Transfer checklist, Product transfer Protocol and Report and other project related documentation.
• Initiating, Tracking and management of Project related Change controls, actions identified, Extension of the change control actions as well as closure.
• Ensuring availability of Supplier documentation and other prerequisites for new API/RM required for respective project.
• Coordination with responsible for ZMID, BOM and material sourcing (PR/PO tracking) and other associated activities for Projects
• Periodic reporting of KPIs defined
• Report / track project achievement/challenges to identify any actions required.