Lead Validator

5 days ago

Malappuram, Kerala, India beBeeValidation Full time ₹ 15,00,000 - ₹ 25,00,000
Validation Lead

Job Overview:

We are seeking an accomplished Validation Lead to spearhead our validation efforts. This individual will be responsible for developing and implementing comprehensive validation strategies, ensuring the quality and reliability of products throughout the development lifecycle.

Main Responsibilities:

  • Design and execute validation plans, protocols, and procedures aligned with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
  • Collaborate with cross-functional teams to define validation requirements and priorities, fostering a culture of excellence and efficiency.
  • Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring seamless integration and optimal results.
  • Perform risk assessments and develop risk mitigation strategies to address potential product risks related to validation, driving proactive decision-making.
  • Drive continuous improvement initiatives to enhance validation processes, increase efficiency, and optimize outcomes.
  • Ensure end-to-end documentation and traceability of validation activities, maintaining transparency and accountability.
  • Provide regular updates and reports on validation activities to senior management and stakeholders, promoting informed decision-making.

Required Skills and Qualifications:

  • 6-12 years of experience in validation or a related field, demonstrating expertise and a track record of success.
  • Experience in collaborating with cross-functional teams and managing relationships with external vendors and contractors, showcasing effective communication and interpersonal skills.
  • Strong knowledge of regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices, staying up-to-date with evolving regulations and standards.
  • Excellent communication and leadership skills, with the ability to inspire and motivate teams to achieve exceptional results.

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