Experienced Senior Validation Professional

20 hours ago

Tiruchi, Tamil Nadu, India beBeevalidation Full time ₹ 15,00,000 - ₹ 18,00,000

Senior Validation Specialist - Pharmaceutical and Medical Device Industry

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We are seeking an experienced Commissioning, Qualification, and Validation (CQV) professional with a strong track record of delivering high-quality projects in the pharmaceutical and medical device sectors.

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The ideal candidate will lead global CQV projects remotely, ensuring compliance with international regulations, including GxP standards. This role involves the preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment.

\Main Responsibilities:\
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  • Develop and execute CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.\
  • Develop, review, and implement CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.\
  • Manage validation master plans (VMP) and system impact assessments to ensure seamless CQV integration into capital and remediation projects.\
  • Collaborate with cross-functional teams to ensure effective CQV support during project execution.\
  • Conduct remote FAT/SAT support, data review, and validation strategy planning to ensure high-quality deliverables.\
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.\
  • Ensure all documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.\
  • Oversee the remote execution of validation test protocols, capturing and resolving deviations as needed.\
  • Drive continuous improvement and risk-based validation strategies aligned with current industry best practices.\
  • Mentor junior CQV engineers and act as a subject matter expert (SME) in audits and inspections.\
  • Stay up-to-date with industry developments, trends, and technologies to maintain expertise and provide valuable insights to the team.\
  • Analyzing processes and developing recommendations for improvements to increase efficiency and effectiveness.\

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