Validation Professional

2 weeks ago

India beBeevalidation Full time ₹ 17,96,100 - ₹ 21,45,900
Validation Expert

We are seeking a seasoned Validation Expert to spearhead our quality and reliability initiatives.

Main Responsibilities:
  • Develop and implement comprehensive validation strategies and processes to guarantee the excellence of products throughout their development lifecycle.
  • Collaborate with cross-functional teams, including development and quality assurance, to define validation requirements and priorities, ensuring seamless integration and effective outcomes.
  • Create and maintain validation plans, protocols, and procedures in accordance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices, promoting compliance and excellence.
  • Oversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring meticulous attention to detail and accuracy.
  • Review and approve test scripts based on objective evidence, guaranteeing test adherence to testing standards and protocols.
  • Conduct risk assessments and develop risk mitigation strategies to address potential product risks related to validation, working closely with key stakeholders like system owners and business owners.
  • Promote continuous improvement initiatives to enhance validation processes, streamline workflows, and boost efficiency, driving innovation and excellence.
  • Manage relationships with external vendors and contractors as needed for validation testing services, ensuring optimal collaboration and results.
  • Maintain end-to-end documentation and traceability of validation activities, including Validation Plans, test plans, test protocols, test reports, validation reports, trace matrix, Change Management, Periodic reviews, Audit Readiness, etc.
  • Provide regular updates and reports on validation activities to Quality Assurance (IT-QA), status to senior management and stakeholders, and raise risks proactively, fostering transparency and accountability.
  • Lead and manage a team of validation analysts, offering guidance, coaching, and mentorship to ensure their professional growth and development, promoting a culture of excellence and teamwork.
  • Ensure training compliance of self and project team members on all customer-related training requirements, upholding the highest standards of knowledge and competence.

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