Validation Manager

2 weeks ago


Kolkata, India PARLE ELIZABETH TOOLS PVT LTD Full time

Key Responsibilities:

  • Knowledge of Pharma machinery testing and validation
  • Knowledge of FAT protocol
  • Background of machine building industry preferred


  • Validation Strategy: Develop and implement validation strategies and protocols for equipment, processes, and systems in accordance with industry standards and regulatory requirements.
  • Team Leadership: Lead, mentor, and manage the validation team. Provide guidance and support to ensure effective execution of validation activities.
  • Compliance: Ensure all validation activities comply with relevant regulatory standards, such as ISO, GMP, and other industry-specific guidelines. Prepare and maintain validation documentation and reports.
  • Planning & Execution: Plan and execute validation projects, including protocol development, execution, and reporting. Coordinate with cross-functional teams to ensure timely and successful validation processes.
  • Continuous Improvement: Monitor and review validation processes to identify areas for improvement. Implement best practices and continuous improvement initiatives to enhance efficiency and effectiveness.
  • Training: Develop and deliver training programs for staff on validation processes, procedures, and compliance requirements.
  • Audit & Inspection: Prepare for and participate in internal and external audits and inspections. Address any findings or observations and implement corrective actions as necessary.

Qualifications:

  • Education: Bachelor’s degree in Electronics and Electrical Engineering is must, or a related field. Advanced degree or certification in validation or quality management is a plus.
  • Experience: Minimum of 8-12 years of experience in validation within a manufacturing or industrial environment, with at least 2 years in a managerial or supervisory role.
  • Skills: Strong knowledge of validation methodologies, regulatory requirements, and quality management systems. Proficiency in validation software and tools.
  • Analytical Abilities: Excellent analytical and problem-solving skills. Ability to interpret complex data and make informed decisions.
  • Communication: Strong written and verbal communication skills. Ability to effectively interact with cross-functional teams and external stakeholders.
  • Leadership: Proven leadership skills with the ability to motivate and manage a team. Strong organizational and project management skills


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