Key Responsibilities
Safety, Quality & Compliance
- Ensure strict adherence to Safety, Health & Environment (SHE) requirements, including LOTO, JSA, and site safety procedures.
- Ensure compliance with cGMP requirements, SOPs, in-house specifications, master batch records, and quality systems.
- Drive data integrity and compliance standards across manufacturing operations.
- Participate in regulatory, customer, and internal audits and ensure timely closure of audit observations and CAPAs.
- Review and monitor deviations, change controls, CPV reports, APQRs, investigations, and quality trends.
Manufacturing Operations
- Lead day-to-day manufacturing and packing operations to achieve production plans and business commitments.
- Review production performance against plan, monitor WIP and semi-finished inventory, and drive plan adherence.
- Ensure optimum utilization of manpower, equipment, and resources to enhance productivity and operational efficiency.
- Monitor production performance and take corrective actions to address operational gaps.
Cross Functional Collaboration
- Coordinate closely with SCM, QA, QC, MSAT, Engineering, Warehouse, and other support functions to ensure smooth execution of manufacturing activities.
- Support technology transfers, product launches, validation activities, and process improvements.
- Ensure timely availability of materials, equipment, and quality clearances to meet production schedules.
Digital Manufacturing & Systems
- Drive effective utilization of digital manufacturing systems including MES, DAS, and other electronic production systems.
- Ensure accurate and timely recording of manufacturing data through digital platforms.
- Leverage production data and performance metrics for decision making and operational improvements.
Operational Excellence
- Drive TPM and continuous improvement initiatives to improve productivity, equipment effectiveness, quality, and cost performance.
- Monitor manufacturing KPIs and implement initiatives to improve operational performance.
- Support implementation of process improvements and best practices across production operations.
People & Industrial Relations
- Lead, coach, and develop production teams to build capability, engagement, and operational ownership.
- Ensure completion of required training, qualification, and skill development programs for production personnel.
- Drive performance management and succession readiness within the function.
- Maintain positive employee and industrial relations, ensuring discipline, engagement, and effective workforce management in a unionized manufacturing environment.
Engineering & Asset Management
- Coordinate with Engineering to ensure adherence to preventive maintenance plans and minimize equipment downtime.
- Support automation, reliability, and improvement projects to enhance manufacturing performance.
Budget & Resource Management
- Support preparation and execution of departmental budgets.
- Drive cost optimization through efficient utilization of manpower, materials, utilities, and equipment.
- Ensure achievement of departmental objectives within approved budgets.
Education
B.Sc. / B.Pharm. / B.Tech/ M. Tech
Experience
- 12-16 years of experience in pharmaceutical manufacturing operations.
- Experience in handling manufacturing teams within a cGMP and regulatory-driven environment.
Skills & Attributes
Technical Skills
- Production Operations & Planning
- cGMP Compliance & Documentation
- Regulatory Audit Handling
- TPM & Continuous Improvement
- Digital Manufacturing Systems (MES/DAS)
- Safety & EHS Management
- Budgeting & Resource Planning
- Data Analysis & Operational Reporting
Behavioural Skills
- Leadership & Team Management
- Stakeholder Management
- Decision Making & Problem Solving
- Strong Communication & Coordination
- People Development & Coaching
- Execution Excellence
- Accountability & Ownership