Manager - Production (Tablet) | Shalina Laboratories Pvt Ltd

Job Purpose

To lead and manage Tablet manufacturing operations at the Jejuri facility, ensuring achievement of production targets, GMP/cGMP compliance, product quality, productivity, manpower efficiency, cost optimization, and timely execution of production plans. The role will also coordinate material movement and production-related activities between the Jejuri Warehouse and External Warehouse.

Role & responsibilities

Production Operations

• Overall responsibility for Tablet production operations at the Jejuri site.
• Plan, monitor, and achieve daily, monthly, and annual production targets.
• Ensure availability of RM, PM, manpower, equipment, and other resources for uninterrupted production.
• Monitor production constraints and coordinate with cross-functional teams for timely resolution.
• Drive capacity utilization, productivity improvement, process optimization, and cycle-time reduction.

GMP & Quality Compliance

• Ensure strict implementation of GMP/cGMP requirements across all production activities and shifts.
• Ensure adherence to SOPs, BMRs, BPRs, and Good Documentation Practices.
• Ensure proper employee gowning, hygiene, and GMP practices across production areas.
• Work closely with IPQA and Site Quality teams to address daily quality observations, shortfalls, deviations, and compliance requirements.
• Identify production risks and implement appropriate mitigation measures.

Production Planning & Documentation

• Prepare production plans and ensure timely execution as per business requirements.
• Ensure preparation and availability of BMRs and required materials from Warehouse.
• Ensure daily dispensing and material movement from Jejuri Warehouse to External Warehouse as per approved production plan.
• Ensure timely completion, review, and submission of BMR/BPR to QA after batch completion.
• Review DPRs and prepare monthly MIS reports and management presentations.
• Ensure timely and accurate SAP transactions related to Production.

Cost & Budget Management

• Prepare and monitor Production CAPEX and OPEX budgets in line with AOP.
• Identify and implement cost-saving initiatives across manpower, materials, processes, and resources.
• Develop resource plans for productivity and cost optimization projects.
• Drive initiatives to improve manufacturing cost efficiency.

Manpower & Team Management

• Ensure availability of manpower as per approved shift schedules and production requirements.
• Manage attendance, leave, shift schedules, and related employee authorizations.
• Conduct technical, GMP, and on-the-job training for production staff and workers.
• Monitor team performance, productivity, discipline, and competency development.

Continuous Improvement & Capacity Enhancement

• Analyze process cycle time and implement process optimization initiatives.
• Identify opportunities for capacity enhancement and support production projections.
• Support new setup requirements, equipment additions, and process improvements.
• Drive initiatives to improve Production Quality Index and overall manufacturing performance.

Risk & Compliance Management

• Identify, assess, and implement mitigation plans for production-related risks.
• Ensure timely closure of CAPAs, deviations, and quality-related actions.
• Support internal, customer, corporate, and regulatory audits and ensure audit readiness.
• Maintain effective coordination with QA, IPQA, QC, Warehouse, Engineering, Planning, and Supply Chain teams.

Preferred candidate profile

Qualifications

• B.Pharm / M.Pharm Mandatory
• Additional qualification in Operations / Management will be an advantage.

Experience

• 12-15 years of experience in pharmaceutical manufacturing.
• Strong experience in Tablet manufacturing in a reputed pharmaceutical organization.
• Proven experience in managing production teams and end-to-end tablet manufacturing operations.
• Strong exposure to GMP/cGMP, production planning, BMR/BPR, SAP, CAPEX/OPEX, and productivity improvement.

Key Competencies

• Tablet Manufacturing & Production Planning
• GMP/cGMP Compliance
• BMR/BPR & Documentation
• Manpower & Shift Management
• Capacity Planning & Productivity Improvement
• Cost Optimization
• CAPEX & OPEX Management
• SAP Production Transactions
• Risk Management
• Cross-Functional Coordination
• Team Leadership & People Development

Key Performance Indicators

• Production plan adherence and target achievement.
• Capacity utilization and manufacturing productivity.
• Process cycle-time improvement.
• GMP and quality compliance.
• Timely BMR/BPR completion and submission.
• Manpower productivity and shift availability.
• Production CAPEX/OPEX adherence.
• Reduction in production deviations and quality observations.
• Cost-saving and continuous improvement initiatives.