Quality Assurance Specialist

1 week ago

Cebu City, Central Visayas, Philippines beBeeValidation Full time ₱4,000,000 - ₱6,000,000
Job Summary

As a Validation Specialist, you will play a critical role in ensuring the quality and reliability of our products by developing and implementing comprehensive validation protocols.

  • Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes to meet regulatory requirements and industry standards.
  • 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.
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.

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