Key Responsibilities:1. Training & Development (T&D):Training Strategy: Design and implement a comprehensive training strategy to enhance employees' skills, knowledge, and overall performance.Learning Programs: Develop and manage learning programs that address both short-term needs and long-term career development of employees.Budget Management: Oversee training budgets and resource allocation, ensuring maximum return on investment for learning programs.Employee Development: Promote continuous learning and provide employees with opportunities to develop their capabilities through workshops, seminars, and e-learning initiatives.Performance Metrics: Establish key performance indicators (KPIs) for training and development and track progress against goals.2. Policy Making:Policy Development: Create and review HR policies related to employee welfare, training, performance, and organizational standards, ensuring compliance with relevant laws and regulations.Policy Implementation: Ensure that policies are communicated effectively to all employees and are consistently enforced across the organization.Change Management: Revise and update policies as necessary, considering changing legislation and business needs.Employee Relations: Maintain open communication with employees to ensure policy implementation is effective and to address concerns.3. Talent Management:Talent Strategy: Develop and implement a talent management strategy to attract, retain, and grow key talent within the organization.Succession Planning: Identify and create a clear pipeline for leadership roles, working to ensure the organizations long-term talent needs are met.Employee Engagement: Design and execute initiatives to improve employee engagement, motivation, and retention.Performance Management: Lead the performance management process, including appraisals, feedback, coaching, and development plans for high-performing employees.Career Development: Promote career growth within the organization, supporting the development of career paths for employees.4. Talent Acquisition:Recruitment Strategy: Develop and execute recruitment strategies to attract top talent in line with organizational goals.Job Descriptions & Advertisements: Work with department heads to create accurate and compelling job descriptions and recruitment advertisements.Interviewing & Selection: Oversee the interview and selection process, ensuring a positive candidate experience and aligning talent with business needs.Onboarding: Lead and enhance the employee onboarding process to ensure a smooth transition for new hires into the company.Employer Branding: Strengthen the employer brand to ensure the organization is recognized as a top employer in the industry.

Regulatory Functional: Compilation of dossier for ROW market as per the country specific requirements (from Module-1 to Module 5) Ensure compliance to county specific regulatory requirements (i.e., Africa, ASEAN, CIA, Gulf, Asia pacific, Latin America) ¢ Ensure labeling compilation as per the country specific requirements¢ Review of DMFs of complex peptide drug substances¢ Post approval activity, variation filing (Major and Minor) as per change proposal recommend by the manufacturing site or client¢ Experienced with handling drug device combination regulations and understand the requirements for submission in line country specific requirement (Prefilled syringes and disposable pens)¢ To assure consistency and adequacy of submissions in line with current regulatory requirements/expectations ¢ Ensure timely response to the deficiencies received from the agencies¢ To communicate & coordinate with different stakeholders within the organization/ third party contract manufacturers to resolve any delay in submissions¢ Life cycle management of products to include renewals, reviewing & approving the change controls and ensures product continuity through filing and timely approvals of variations. Support the continuing activities through coordination with various stakeholder¢ Approval package compilation and provides support for lunching of the approved product

Role & responsibilities Objective:To ensure efficient and optimized utilization of production and packing lines for Oral Solid Dosage (OSD) forms by coordinating machine loading, balancing workflows, and managing dependencies related to QC release, client schedules, and communication with department heads. The role also requires effective handling of rolling client forecasts to align production planning with firm POs and tentative demands.Key Responsibilities:1. Production and Packing Line Planning: Create and manage detailed production schedules, ensuring machine availability and minimal downtime. Ensure coordinated loading of production and packing lines to prevent bottlenecks. Maintain a daily and weekly machine utilization plan aligned with client requirements and delivery timelines.2. Rolling Forecast Management: Receive and process rolling forecasts from clients, typically structured as: Month 1 & Month 2: Firm Purchase Orders (POs). Month 3: Tentative demand, subject to updates. Continuously update production schedules each month as forecasts are refined. Align resources and capacities with forecast changes to avoid production disruptions.3. Client Coordination: Communicate with clients to confirm timelines, address changes in forecasts or priorities, and update them on batch statuses. Share reports on batch progress, planned timelines, and any delays with clients. Manage last-minute client changes (e.g., batch priority changes) with minimal disruption to operations.4. Line Balancing: Assess and implement optimal product flows to avoid machine idling or overload. Allocate resources (manpower and materials) to match planned machine capacities. Balance tasks between multiple production and packing lines to minimize cycle time differences.5. Coordination with Cross-Functional Teams: Quality Control (QC): Coordinate QC sampling, analysis, and release of materials and batches to avoid delays. Production and Packing Teams: Align schedules with department heads to ensure resource availability (e.g., operators, shift plans, changeover times). Quality Assurance (QA): Ensure IPQA approvals and validations are coordinated with the line schedule to avoid interruptions.6. Machine Changeovers and Preventive Maintenance Coordination: Schedule production batches in line with planned maintenance activities to avoid clashes. Minimize changeover times between batches by optimizing machine cleaning and setup times.7. Capacity Utilization Tracking and Reporting: Track and report machine utilization and downtime to identify areas for improvement. Generate reports on daily output vs. planned production and packing to management. Maintain data on batch adherence to TAT (Turnaround Time) targets.8. Deviation Management: Handle deviations in production schedules due to QC delays, machine breakdowns, or manpower shortages by reworking loading plans. Communicate critical deviations to management and propose mitigation plans.9. MIS (Management Information System) and Dashboard Reporting:Key MIS Reports to be Generated: Daily Production Report: Shift-wise machine loading, batch progress, and QC release status. Rolling Forecast vs. Production Plan: Track alignment of monthly rolling forecasts against actual production. Weekly Planning Report: Consolidated report showing machine utilization, pending batches, and deviations. Monthly Summary: Total batches completed, machine uptime, changeover time analysis, and TAT compliance. Client Dashboard: Customized reports for clients showing batch status, expected release dates, and shipment timelines. Deviation and RCA Report: Summary of major deviations during the month with RCA (Root Cause Analysis) and CAPA (Corrective and Preventive Actions).Key Dashboard Metrics: Production Metrics: Planned vs. Actual Batch Production Machine Utilization (%) Changeover Time (minutes per batch) QC Metrics: Sampling and Release TAT (Turnaround Time) Number of Pending QC Approvals Packing Metrics: Packing Line Utilization (%) Planned vs. Actual Output Deviation Metrics: Number of Line Downtimes Number of QC Holds and Reasons Client Metrics: Number of Client Deliverables Met On-Time (%) Pending Client ApprovalsDashboard Formats: Visual representation: Bar charts for machine utilization, pie charts for deviation categories, and timelines for TAT adherence. Real-time updates: Link data from the ERP/LIMS system to generate automatic daily updates. Drill-down options: Ability to view department-specific or batch-specific data for detailed analysis.10. Regulatory Compliance and Documentation: Ensure production schedules are compliant with regulatory requirements. Maintain records of planned vs. actual production for regulatory inspections and internal audits.Key Deliverables:1. Daily Machine Loading Plans: Detailed loading plan for each shift, including batch allocation.2. Rolling Forecast vs. Production Plan Reports: Comparison of client forecasts vs. actual production.3. MIS Reports: A comprehensive set of production, QC, and client reports.4. Dashboards: Visual, real-time summaries of production and packing status.5. Deviation Analysis: Root cause analysis reports for any deviations from the production plan.Educational Qualifications for Candidate Selection: Minimum Qualification: Bachelors Degree in Pharmacy (B.Pharm), Engineering (Mechanical, Industrial, or Production), or Science (B.Sc.). Preferred Qualification: Master’s in Pharmacy (M.Pharm), MBA in Operations, or certification in Production Planning (such as APICS, Lean Six Sigma, or SAP ERP certification). Experience: Essential: 5+ years of experience in pharmaceutical manufacturing/CMO operations, specifically in OSD production planning. Desirable: Experience in handling client coordination for rolling forecasts and managing ERP/MIS-based planning systems.Additional Skills Required: Proficiency in Excel, ERP systems, and scheduling tools (SAP, Oracle, MES, etc.). Strong analytical and problem-solving abilities. Excellent communication skills for cross-functional coordination and client management. Proficiency in dashboard creation tools (Power BI, Tableau) for MIS reporting. Strong organizational and multitasking abilities to handle rolling changes in forecasts without compromising deadlines.Perks and benefits