Asst. Manager / Manager – Section Head (Validation / Qualification / CSV)

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Role Summary

Validation & Qualification section

Process Validation, Cleaning Validation, Equipment & Facility Qualification

Computer System Validation (CSV)

managerial role

Key Responsibilities

Strategic Planning & Oversight:

• Lead the development and implementation of the site Validation Master Plan (VMP).
• Oversee all validation and qualification activities (Process, Cleaning, Equipment, Facility, CSV) to ensure compliance with cGMP and regulatory expectations.
• Allocate resources and manage workload for validation team to ensure timely execution.
  

Process & Cleaning Validation

• Review and approve process validation protocols and reports in line with lifecycle approach.
• Ensure cleaning validation activities meet regulatory expectations and site-specific risk assessments.
• Support risk-based re-validation and continued process verification programs.
  

Equipment / Facility / Utility Qualification

• Oversee IQ, OQ, PQ of new and existing equipment, HVAC systems, and utilities.
• Ensure periodic requalification and deviation handling.
• Review and approve all qualification documents and summary reports.
  

Computer System Validation (CSV)

• Ensure GxP software and computer systems are validated as per GAMP 5 and 21 CFR Part 11 requirements.
• Collaborate with IT, Engineering, and external vendors for new system qualification, periodic reviews, and change management.
• Review and approve CSV documentation (URS, RA, IQ/OQ/PQ).
  

Compliance & Audit Readiness

• Ensure all validation activities are audit-ready and compliant with USFDA, MHRA, EU-GMP, WHO, and other regulatory guidelines.
• Lead responses to regulatory queries and participate in audits and inspections.
• Maintain robust document control and support data integrity compliance across systems.
  

Team Leadership & Development

• Lead a team of executives and senior executives in the validation function.
• Provide technical guidance, training, and performance feedback.
• Foster a culture of continuous improvement and compliance.
  

Candidate Profile

Qualification:

Experience:

• Sound knowledge of GMP guidelines, ICH Q8–Q10, GAMP 5, and regulatory requirements
• Prior experience in handling regulatory audits (USFDA / MHRA / EU-GMP / WHO / ANVISA, etc.)
  

Desired Skills

• Strong leadership and decision-making capabilities
• Excellent documentation, communication, and cross-functional coordination skills
• Proficiency in QMS systems, validation documentation tools, and MS Office
• Problem-solving mindset with a focus on risk-based, data-driven validation
  

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