Full Time Quality Compliance Specialist Jobs, Salary up to SGD 7,500 in NUSANTARA PRIME CONSULTING PTE LTD Southwest (Singapore) - Maukerja

Main Responsibilities:

• Conduct training for data integrity (site wide refresher and NEO 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 (such as hot topic rehearsal with SMEs and storyboard)
• 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

About You:

• At least 6 years QA experience in GMP manufacturing operations (API/Bio manufacturing) required, preferably in Quality Operations/Compliance
• Experience in internal audit and external inspection preferred
• Knowledge in Data integrity and Data governance principles required
• Strong knowledge in Engineering operations, OT and IT systems (Deltav, MES system, SAP, LIMS etc) and system interface preferred Quality and Compliance mindset required
• High adaptability and ability to lead and work with cross functional team required
• Strong communication and writing skills required
• Team player required

Pay: $5,000.00 - $7,500.00 per month

Experience:

• Quality audits: 3 years (Preferred)
• Pharmaceutical: 3 years (Preferred)
• GMP: 3 years (Preferred)

Work Location: In person