Senior Quality Assurance Specialist

2 days ago

Antipolo City, Calabarzon, Philippines beBeeValidation Full time ₱5,000,000 - ₱8,000,000
Job Title

A Validation Engineer position at a pharmaceutical company supports the organization's operations by ensuring processes, equipment, and computerized systems meet regulatory requirements.

About the Role
  • This role focuses on Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering to guarantee compliance with industry standards.
Responsibilities
  • Develop commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Execute CSV activities including defining user requirements, developing test scripts, and conducting validation testing.
  • Collaborate with cross-functional teams to ensure systems and processes meet 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.
  • Participate in change control processes to assess the impact of changes on validated systems.
  • Investigate and resolve deviations related to validation activities.
  • Proactively identify opportunities for process improvements in validation activities.
Qualifications
  • Bachelor's degree in Engineering or a related technical field.
  • Minimum 3-5 years of validation engineering experience in the pharmaceutical industry.
  • Demonstrated experience in CQV and CSV Engineering.
  • Strong technical writing skills.
  • Strong understanding of regulatory requirements and Data Integrity.
  • Experience with risk-based validation approaches and methodologies.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
EEO Statement

The organization is committed to a policy of equal employment opportunity and complies with all applicable federal, state and local laws concerning employment discrimination.

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