- Singapore
全职 Quality Compliance Specialist 工作, 薪水 up to SGD 7,500, NUSANTARA PRIME CONSULTING PTE. LTD. 公司招聘中 - Ricebowl
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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
Contract Duration: 12 months contract
Nusantara Prime Consulting Pte. Ltd (NPC)
is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.
Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.
Our Mission
With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.
Our Vision
To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.
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
Contract Duration: 12 months contract
Nusantara Prime Consulting Pte. Ltd (NPC)
is a Singapore based private limited company that focuses on technical consulting solutions led by a team of industry practitioners.
Our Specialist Services include Pharmaceutical focus on Process/Project Engineering and Design, Project Management, Technology Transfer, Regulatory affairs, Commissioning, Qualification, Validation, Quality Assurance & Control and Waste Water processing consultation with aim of ZLD (Zero Liquid Discharge) for a circular economy to clients in the Biopharmaceuticals, Life Sciences and Food and Beverage (F&B) industry in the ASEAN region.
Our Mission
With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.
Our Vision
To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically.
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