Validation and Assurance Expert

1 day ago

Manila, National Capital Region, Philippines beBeeExpertise Full time ₱5,000,000 - ₱7,500,000
About the Role

This is a remote Validation and Assurance Expert position supporting M-F 8pm - 5am PH schedule. The role focuses on ensuring processes, equipment, and computerized systems meet regulatory requirements and industry standards.

Key Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Execute computer system validation activities, including defining user requirements, developing test scripts, and conducting validation testing.
  • Collaborate with cross-functional teams to ensure that systems and processes meet regulatory and quality standards.
  • Perform risk assessments and develop validation plans to mitigate potential risks.
  • Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs).
  • Participate in change control processes to assess the impact of changes on validated systems.
  • Investigate and resolve deviations related to validation activities, ensuring compliance with regulatory requirements.
  • Proactively identify opportunities for process improvements in validation activities.
  • Stay up-to-date with industry trends, regulatory changes, and best practices related to CQV and CSV.
Requirements
  • Bachelor's degree in Engineering or related technical field.
  • Minimum of 3-5 years of validation engineering experience in the pharmaceutical industry.
  • Demonstrated experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
  • Strong technical writing and documentation skills.
  • Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
  • Experience with risk-based validation approaches and methodologies.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Detail-oriented with strong organizational abilities.
Equal Opportunity Employment

The organization is committed to equal opportunity employment and prohibits discrimination against qualified employees, interns, and applicants in all aspects of employment. This commitment includes recruitment, interviewing, hiring, evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, and employer-sponsored activities and programs. Discrimination will be made without regard to an applicant's, employee's, or intern's actual or perceived race, color, religion, sex, national origin, age, disability, genetic information, or any other status protected by law.

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