Quality Management System (QMS)

• Manage and maintain the site Quality Management System (QMS) in compliance with cGMP requirements.
• Review, approve, and maintain departmental SOPs, policies, protocols, and technical documents.
• Review and approve Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
• Govern Change Controls, Risk Assessments, Deviations, Investigations, OOS/OOT, CAPA, customer complaints, and product recalls.
• Ensure proper documentation control and compliance with quality procedures.

Quality Assurance & Compliance

• Ensure compliance with cGMP, GLP, GDP, and regulatory standards.
• Conduct line clearances for dispensing, manufacturing, filling, and packing operations.
• Manage product release processes for raw materials, intermediates, and finished goods.
• Review and approve packaging artwork and quality documentation.

Qualification & Validation

• Lead equipment, utility, facility, and process qualification activities.
• Manage DQ, IQ, OQ, PQ protocols and execution.
• Drive process validation and cleaning validation programs.
• Ensure all validation activities are completed as per regulatory requirements.

Audit & Inspection Management

• Conduct self-inspections and internal audits.
• Lead customer, regulatory, and third-party audits.
• Ensure timely CAPA implementation and closure.
• Maintain audit readiness at all times.

Laboratory & Instrument Management

• Oversee laboratory operations and testing activities.
• Ensure calibration of laboratory and production equipment through NABL-accredited laboratories.
• Supervise troubleshooting and maintenance of quality control instruments.
• Maintain laboratory documentation and records.

Environmental & Regulatory Monitoring

• Coordinate testing of:
  • Ambient Air Quality
  • Drinking Water
  • Effluent Water
  • Noise Levels
  • Lux Levels
• Ensure compliance with FMCG and food safety standards.

Team Management & Training

• Lead and supervise QA/QC teams.
• Conduct quality-related training programs.
• Develop team competencies and quality awareness.
• Ensure adherence to training schedules and compliance programs.

Cross-Functional Coordination

• Work closely with Production, Stores, Procurement, and other departments.
• Support production operations when required.
• Drive continuous improvement initiatives and quality culture across the facility.

Performance Monitoring & Reporting

• Define and monitor Quality KPIs.
• Analyze trends and implement corrective actions.
• Drive cost optimization initiatives without compromising product quality.
• Prepare quality reports and management reviews.

Educational Qualification

• B.Pharm / M.Pharm OR
• M.Sc. (Chemistry / Microbiology) OR Equivalent Qualification

Preferred

• Quality Management Certifications
• Regulatory Compliance Certifications
• GMP / ISO Certifications

Experience

• 10 to 15 years of experience in:
  • FMCG Manufacturing
  • Nutraceutical Manufacturing
  • Pharmaceutical Manufacturing
  • Powder Processing Industry
• Minimum 3 to 4 years in a managerial or supervisory role.

Technical Knowledge

Quality Systems

• cGMP
• GLP
• GDP
• Change Control
• CAPA
• OOS / OOT
• Deviation Management
• Risk Assessment
• Product Recall Management

Qualification & Validation

• DQ, IQ, OQ, PQ
• Process Validation
• Cleaning Validation

Laboratory & Compliance

• Analytical Instrumentation
• Calibration Requirements
• NABL Standards
• Environmental Monitoring
• Food Safety Compliance

Software Skills

• QMS / eQMS Systems (TrackWise, Caliber, or equivalent)
• LIMS (Laboratory Information Management System)
• SAP QM Module
• MS Office (Advanced Excel)
• Document Management Systems

Soft Skills

• Strong Leadership and Team Management
• Audit Management
• Problem Solving & Decision Making
• Risk Assessment & Compliance Management
• Cross-Functional Coordination
• Excellent Communication Skills
• Attention to Detail
• Quality-First Mindset