Position Summary:

The role involves managing and optimizing mixing, filling, and packaging operations in compliance with global regulatory standards. The candidate will drive operational excellence, ensure regulatory compliance, lead process improvement initiatives, and support project and capacity planning activities in pharmaceutical manufacturing.

Educational & Experience Requirements:

Education:

Bachelor's degree in Pharmacy (B Pharm) or Chemical Engineering.
Graduated from reputed universities/colleges such as NITs, RECs, or Tier-1 state colleges.

Experience:

3 to 7 years of experience in manufacturing or production.
Experience in pharmaceutical or healthcare manufacturing is preferred.
Exposure to multinational corporations (MNCs) is an advantage.

Key Responsibilities:

Mixing and Filling Operations

Expertise in liquid-liquid and solid-liquid mixing and filling processes.
Manage packaging operations with focus on accuracy, hygiene, and efficiency.

Regulatory Compliance

Implement and oversee manufacturing practices per FDA, WHO, and cGMP guidelines.
Ensure adherence to global quality and safety standards.

Project Management

Lead projects for cycle time reduction, productivity improvement, and line balancing.
Drive cross-functional teams toward achieving project KPIs and milestones.

Safety & Risk Analysis

Conduct Pre-Startup Safety Reviews (PSI), HAZOP, and Process Hazard Analysis (PHA).
Lead process hazard management for existing products to ensure safe operations.

Process Analysis & Optimization

Perform process capability studies, what-if analyses, and variability studies.
Define and refine key process parameters such as cycle time, lead time, takt time, and line balancing.

Process & Equipment Qualification

Lead process qualifications, change control, and IQ/OQ activities.
Ensure equipment calibration and maintain validation records.

Operational Excellence

Foster shop floor discipline, team engagement, and a culture of 5S.
Drive continuous improvement using SPC and process mapping techniques.

Documentation & Training

Maintain up-to-date production documentation and reporting.
Conduct SOP and best practice training for team members.

Customer-Centric Quality Management

Conduct root cause analyses for customer complaints and deviations.
Implement Corrective and Preventive Actions (CAPA) to improve quality.

Operational Management

Monitor and maintain line flow, output, and process control for optimal efficiency.
Develop capacity plans, shift scheduling, material issuance, and manpower allocation.
Use SAP applications (preferred) for planning, tracking, and analysis.

Improvement Initiatives & Process Redesign

Lead yield improvement, OEE, and automation projects.
Apply industrial engineering techniques (cycle time, method, and work studies).
Identify and implement process redesigns, layout modifications, and workflow enhancements.

Certifications:

Six Sigma Green Belt (preferred, not mandatory).

Regulatory & Industry Compliance:

Proven experience with FDA, WHO, and cGMP standards.
Understanding of ICH and WHO guidelines related to pharmaceutical manufacturing and quality systems.

Technical Proficiency:

Hands-on experience in commissioning and qualification processes (IQ, OQ, PQ).
Familiarity with validation protocols and regulatory documentation.

Corporate Experience & Career Stability:

Experience working in structured MNC environments.
Stable career progression with limited job-hopping.

Production Shift Supervisor