• Conduct training for data integrity (site wide refresher and NEO hire training) and review documents related to Data Integrity (Audit trail review, and Data Integrity Risk assessment etc)
• Conduct internal audits and support internal audit CAPAs follow-up (discussion of response) and management of open audit CAPAs
• Serve as Compliance Partner for inspection readiness for assigned department
• Support external inspections (logistics and backroom support)
• Support for other areas (Quality risk management, Quality Plan, QMR tasks and regulatory submission) in terms of management of open tasks, revision/routing of documents
• Scope of Compliance team: Internal audit & External inspections
• Site Inspection Readiness
• Regulatory submission
• Site Quality Metrics and Management review
• Quality Plan (Improvement projects)
• Quality Risk Management
• Data Integrity

Requirements:

• min. Degree in any related discipline and above
• Possess min. 5-6 years prior working experience in QA / QO in manufacturing plant environment
• Able to start work immediate or within short notice

Interested candidates please send in your updated resume in MS Word Format:

[email protected]
Subject: QA Compliance Specialist

EA Personnel: Kate Leau Wei Xuan (R1552331)
Company Registration No. 99C4599