Support Statement

Support departmental operation to assure quality and compliance to the regulatory requirements. Provides GLP/GCP/CAP audit and inspection support to the Quality Assurance Section and reports to upper management.

Responsibilities

Major Responsibilities

• Monitor updates for regulatory legislations and/or guidelines.
• Conduct review of documents, procedures, facilities, etc., to ensure compliance to the regulatory requirements.
• Perform review and quality assurance for reports and documents to be submitted to the regulatory departments.
• Review the responses of the audit or inspection findings for appropriateness and completeness.
• By following approved procedure and schedules, conducting audits either independently or collaboratively with other QA auditors.
• Ensure timely completion of routine QA procedures.
• Work collaboratively with each department head in the assessment of vendors' qualifications.
• Assisting in project related or non-project related audits/inspections conducted by customer or regulatory authorities.
• Write and issue audit reports or any non-conformances form in accordance with SOPs.
• Ensure that audit findings are clearly made to the relevant project team members, department heads and upper management.
• Participate in the investigation of non-compliance, problem reporting, or complaint issues. Follow through to verify corrective/preventive actions are appropriate and enforced as well as tracking and monitoring performances of the actions taken before case closed.
• Perform housekeeping on documents generated as a result of QA activities.
• Provide inputs to the development of departmental quality system process.
• Manage SOPs according to company policy or regulatory agencies.
• Conduct provisional tasks assigned by upper management.

Qualifications

Qualifications & Experience

Education

• Bachelor's degree in a scientific discipline. Advanced degree is a plus.

Knowledge, Skills, and Abilities

• Good knowledge of regulatory requirements.
• Good communication skills.
• English reading and writing skills.
• Computer skills.
• Detail orientated.

Experiences

Lab Quality Assurance II

• 3 or more-year experience in GLP, GCP, or CAP industry is a plus.
• 2 years of CRA is a plus.

Lab Quality Assurance III

• 5 or more-year experience in GLP, GCP, or CAP industry is preferred.
• 3 years of CRA is a plus.

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