Job
Description
The PM role oversees the planning, execution, and monitoring of projects related to the development, manufacturing, and supply chain management of Active Pharmaceutical Ingredients (APIs). This role involves working closely with cross-functional teams to ensure project objectives are met within timelines, budgetary constraints, and regulatory requirements. Key Responsibilities: Project Planning and Initiation: Collaborate with stakeholders to define project scope, objectives, and deliverables. Develop comprehensive project plans, timelines, and resource allocation strategies. Conduct feasibility studies and risk assessments to identify potential challenges and mitigation strategies. Project Execution and Monitoring: Coordinate activities across different departments, including R&D, manufacturing, quality assurance, and regulatory affairs. Monitor project progress, identify deviations from the plan, and implement corrective actions as necessary. Ensure adherence to project milestones, timelines, and budget constraints. Facilitate regular project meetings, providing updates to stakeholders and addressing issues proactively. Resource Management: Allocate resources effectively to ensure project tasks are completed on time and within budget. Work closely with functional managers to resolve resource conflicts and optimize resource utilization. Provide leadership and guidance to project team members, fostering a collaborative and high-performance work environment. Quality and Compliance: Ensure compliance with relevant regulatory guidelines, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other industry standards. Implement quality management systems to maintain product quality and ensure regulatory compliance throughout the project lifecycle. Conduct internal audits and oversee external audits to assess compliance with regulatory requirements. Communication and Stakeholder Management: Serve as the primary point of contact for internal and external stakeholders regarding project status, issues, and resolutions. Communicate project objectives, progress, and challenges effectively to key stakeholders, including senior management. Build and maintain strong relationships with customers, suppliers, and regulatory agencies to facilitate project success. Collaboration with various stakeholders from function like Manufacturing, QC, QA, SCM, safety teams for required support by respective functions such RM procurement, VQ, analysis & release, complying to schedules. Other Key Focus areas: Close monitoring of projects in terms of timelines and budgets Timely escalation of delays and seeking support from CFT and management to bridge gaps Identifying bottlenecks and involve respective teams for resolution/planning Conducting weekly/bi-weekly review meetings with CFT and with management Track the deliverables committed to FR&D for development/pilot bio/scale up and EB batches. Ensuring required support from CFT for successfully completing AMV at external/internal labs Ensuring necessary approvals through NFA for RM procurement and new equipment procurements/facility establishment (CAPEX)
