Executive / Sr. Executive - Perform Program

Job Title:  Executive / Sr. Executive, Perform Program.

Qualification: B. Pharm / M. Pharm with 3 to 5 years of experience in Pharmaceutical Quality Assurance or Production.

(Female candidates shall have more preference)

• Candidate with sound experience in the oral solid dosage Production process from disposal to Secondary packing.
• 3-5 years of exposure either in Quality Assurance (IPQA, QMS) or Manufacturing section including the Manufacturing or packing section

Specific Requirements:

• Experience in 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, and Tracking

Job Summary:

A key member of Perform Program function in Site Strategy Execution team. Executive/Sr. Executive Perform program is primarily responsible for supporting Perform Program Manager for successful Project 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 also be accountable for sustaining the overall tracking and coordination system (reporting and governance) established as a common way of working and measuring across the various functions and sites involved.

All the above activities shall be performed in line with Zentiva’s compliance requirements (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

KEY ACCOUNTABILITIES

Process

• Responsible for supporting the 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.
• Management of all identified project actions at the site using the project plan and checking their accomplishment for successful project execution.
• Participation and engagement with the site as well as the global project team beginning from Product feasibility and technology transfer till launch/supply switch for the new development/internalized transfer products.
• Understanding communication of relevant information associated with 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 for cooperating with the site as well as external stakeholders, and 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 optimization opportunities.
• Other activities priority assigned by Perform Program Manager.

Compliance

• Adherence to Zentiva Quality, HSE, and organizational compliance
• Ensure timely completion of training 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 on the requirement of the new standard for future development of processes/products

Monitoring and Improvement:

• Provides project updates and reports on project progress to both sites as well as global management using Process Flow Tracker or a suitable project tracker established.
• Coordination and Follow-up with cross-functional project team 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 the 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.