Job Description

Job Summary:

The Plant Head will be responsible for

overall management, planning, and control of plant operations

-- ensuring optimum utilization of manpower, materials, and machinery while maintaining the highest standards of

productivity, quality, safety, and regulatory compliance

(ISO 13485, CE, MDR, GMP).

This role requires a strong leader who can align cross-functional teams (Production, QA, QC, Maintenance, Purchase, Stores, HR, ) toward achieving company goals in

efficiency, cost control, and on-time delivery

, while driving a culture of continuous improvement.

Key Responsibilities:1. Strategic Planning & Operations Control

Lead day-to-day plant operations to achieve monthly and annual production targets. Develop and implement production plans based on demand forecasts and export schedules. Monitor KPIs for

OEE, productivity, yield, downtime, rejection, and delivery performance.

Optimize production planning, batch scheduling, and resource allocation to minimize bottlenecks.

2. Quality, Regulatory & Compliance

Ensure strict adherence to

ISO 13485:2016, CE, MDR, and GMP

standards across all processes. Collaborate with QA and QC to maintain product quality, conduct internal audits, and resolve non-conformities. Maintain full traceability and documentation for batch manufacturing, sterilization, and packaging. Support internal and external audits (MOH, clients, notified bodies).

3. Team Leadership & Development

Lead a multidisciplinary team across

Production, QA/QC, Maintenance, Purchase, Store, and HR

. Define departmental KPIs and conduct regular performance reviews. Train and motivate employees to ensure accountability, productivity, and safety compliance. Foster a culture of teamwork, discipline, and continuous learning.

4. Cost & Efficiency Management

Monitor manufacturing costs, wastage, and material utilisation to improve profit margins. Implement Lean Manufacturing, Kaizen, and 5S principles for continuous improvement. Review cost sheets, BOM accuracy, and process efficiency for cost optimisation.

5. Maintenance & Facility Management

Oversee preventive and breakdown maintenance of machinery, utilities, AHUs, and ETO sterilisation units. Ensure uninterrupted production through effective maintenance planning. Coordinate for calibration, validation, and facility upkeep as per GMP norms.

6. Production Documentation & Traceability

Ensure timely Flow of

BMR (Batch Manufacturing Record), BPR (Batch Packaging Record)

, and other production documents. Maintain full traceability from raw material to dispatch. Coordinate with QA for change control, deviation, CAPA, and process validation.

7. Safety, Environment & Compliance

Ensure implementation of

EHS (Environment, Health & Safety)

standards. Conduct regular safety drills, equipment audits, and compliance checks. Maintain hygienic and controlled manufacturing environments as per cleanroom classifications.

8. Cross-Functional Coordination

Collaborate with

Purchase, Sales, Planning, and Finance

to ensure smooth operations. Review production vs. dispatch schedules and support on-time shipment for export orders. Participate in management review meetings and strategic business planning.

Key Skills & Competencies:

Strong leadership, communication, and analytical abilities. In-depth understanding of

medical device manufacturing processes

(injection molding, assembly, ETO sterilization, packaging). Familiar with

ISO 13485 documentation, CE marking, and GMP

systems. Sound knowledge of production planning, maintenance, inventory, and manpower management. Proficiency in MS Office / ERP systems. Decision-making and problem-solving mindset.

Qualification & Experience:

Bachelor's / Master's degree in

Engineering, Industrial Management, or Production.

Minimum

5-10 years

of experience in manufacturing, with at least 2

years in a senior leadership role

(preferably in

medical devices, pharma, or cleanroom manufacturing

). Hands-on experience with

ISO 13485 audits, ETO sterilization, and CE compliance

preferred.
Job Types: Full-time, Permanent

Pay: ₹35,000.00 - ₹75,000.00 per month

Work Location: In person