Zentiva is inviting applications for the role of Senior Executive – Portfolio Program at its Ankleshwar location in India. This opportunity is suitable for pharmacy graduates or postgraduates with experience in pharmaceutical Quality Assurance or Production, especially in oral solid dosage forms and portfolio project coordination.

Job Details

Job Description

The selected candidate will be a key member of the Portfolio Program function within the Site Strategy Execution team. The role supports the Portfolio Program Manager in planning, tracking and coordinating project activities for ongoing and new projects such as Product Transfer, New Development, Product supply switch, New product launch and alternate source implementation.

The position is responsible for supporting project execution in line with Zentiva roadmap requirements and ensuring activities are completed in line with Quality and Safety compliance expectations.

Key Responsibilities

• Support the Portfolio 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.
• Coordinate project activities to support timely project completion and on-time-in-full commitments.
• Understand technology transfer of new products from development scale to commercial production.
• Prepare, review and execute Technology Transfer Protocols, MFRs, BMRs and Validation Protocols / Reports.
• Execute validation / registration batches at the shop floor.
• Manage identified project actions at site using project plans and track their completion for successful execution.
• Engage with site and global project teams from product feasibility and technology transfer through launch or supply switch.
• Communicate relevant project information received from Development / Portfolio teams to cross-functional technical team members.
• Conduct regular calls and project team meetings across relevant organizational groups.
• Cooperate with site and external stakeholders, including transfer teams, for Product Transfer, New Development, COGs optimization, capacity utilization, alternate supplier implementation, product life cycle management and process optimization.
• Participate in and manage regular cross-functional Launch Management meetings to ensure timely delivery of work packages.
• Support continuous improvement activities, cost engineering techniques and operational excellence initiatives.
• Ensure adherence to Zentiva Quality, HSE and organizational compliance.
• Ensure timely completion of training to comply with Quality and HSE requirements.
• Capture and share good practices across the organization.
• Provide feedback to process / function owners on new standards required for future development of processes / products.
• Provide project updates and progress reports to site and global management using Process flow Tracker or a suitable project tracker.
• Coordinate with shop floor team members for transfer project / source change related activities in production areas.
• Coordinate and follow up with Production, Quality, Warehouse – Supply chain, Procurement and Controlling teams as per action items and maintain current tracker status.
• Prepare and revise project-related documentation and databases, including Product Transfer checklist, Product transfer Protocol and Report and other project documents.
• Initiate, track and manage project-related change controls, identified actions, extension of change control actions and closure.
• Ensure availability of supplier documentation and other prerequisites for new API/RM required for respective projects.
• Coordinate ZMID, BOM, material sourcing, PR/PO tracking and associated project activities.
• Report periodic KPIs and track project achievements or challenges to identify required actions.

Qualification

• Graduate / Post Graduate in Pharmacy.
• Experience in Pharmaceutical Quality Assurance or Production.
• Sound experience in documentation and execution of oral solid dosage production process from dispensing to secondary packing.
• Exposure to Quality Assurance functions such as IPQA and QMS, or Manufacturing / Production including manufacturing or packing section.
• Experience in IPQA, QMS or Production activities of Solid Dosage Form, specifically tablets.
• Worked with EU regulatory-approved pants.
• Knowledge of SAP/ERP and QMS tools such as eDMS, Trackwise and Quality Forward.
• Experience in compilation and documentation of pharmaceutical documents.
• Strong communication, coordination, tracking and shop floor exposure.
• Process knowledge and awareness of Quality/QMS tools.
• Stakeholder management skills.

Experience

Candidates should have 3-6 years of experience in Pharmaceutical Quality Assurance or Production.

How to Apply

Interested candidates can apply online through the official Zentiva application link below.