Plant Head Quality-Gujarat

Role & responsibilities

Position- Plant Quality Head

Reports To:

Team Size:

Job Location- Gujarat

Position Summary

Unit Quality Head

Key Responsibilities

1. Quality Management & Compliance

• Ensure strict adherence to

  cGMP

  ,

  GLP

  ,

  Schedule M

  ,

  WHO-GMP

  ,

  US FDA

  , and other applicable regulations.
• Implement and maintain a robust

  Quality Management System (QMS)

  including:
• Deviations
  
• CAPA
  
• Change Control
  
• OOS/OOT
  
• Market Complaints
  
• Product Quality Reviews (PQR)
  
• Lead internal audits and ensure timely closure of observations.
  
• Prepare for and manage audits/inspections by

  CDSCO, FDA, WHO, US FDA, EU agencies, and customer audits

  .
• Maintain and update all statutory licenses, regulatory documentation, and compliance records.
  

2. Quality Assurance (QA)

• Oversee review and approval of

  BMR/BPR

  , ensuring compliance before batch release.
• Approve and monitor validation activities including:
  
• Process validation
  
• Cleaning validation
  
• Equipment qualification
  
• Analytical method validation
  
• Ensure implementation of

  Good Documentation Practices (GDP)

  .
• Conduct quality risk assessments and support continuous improvement initiatives.
  
• Ensure full compliance with

  Data Integrity (ALCOA+)

  across all systems and departments.

3. Quality Control (QC)

• Lead QC activities including sampling, testing, and release of:
  
• Raw materials
  
• Packing materials
  
• In-process materials
  
• Finished products
  
• Oversee calibration, qualification, and maintenance of QC instruments.
  
• Review analytical results, specifications, and methods.
  
• Drive investigations related to

  OOS/OOT

  , lab incidents, and deviations.
• Manage advanced analytical instruments such as:

  GC, HPLC, GC-MS, ICP, HPTLC

  .

4. People Leadership

• Lead and mentor a team of

  2 managers + 15-16 QC/QA staff

  .
• Build a strong culture of compliance, quality ownership, and continuous improvement.
  
• Conduct performance reviews, identify capability gaps, and plan training interventions.
  
• Encourage cross-functional collaboration and high performance.
  

5. Coordination & Communication

• Work closely with

  Production, Engineering, SCM, R&D, and Regulatory Affairs

  teams to ensure smooth quality operations.
• Represent the unit in corporate quality reviews, management meetings, and decision-making forums.
  
• Identify and drive opportunities for

  digitalization & automation

  in quality systems and documentation.

Competencies

• Strong leadership and decision-making capability.
  
• Excellent communication and interpersonal skills.
  
• Analytical mindset with strong problem-solving ability.
  
• High ethical standards, integrity, and regulatory understanding.
  
• Ability to manage multiple priorities and work under pressure.

Preferred candidate profile

• Experience:

• Minimum

  10 years

  in pharmaceutical medicine manufacturing.
• At least

  3 years in a Unit Quality Head / Quality Head / Senior Quality leadership role at Plant

• Must Have exp in US FDA & India FDA
  

• Knowledge:

• Comprehensive understanding of

  Indian Drug Rules

• Strong understanding of Indian Drugs & Cosmetics Act, Schedule M, WHO-GMP, US FDA, India FDA requirements.
  
• Hands-on experience with

  Data Integrity

  , QMS, Validation, and Regulatory Compliance.
• Experience handling audits of

  pharma giants .

• Must have Experience in Pharma Industries