Quality Compliance Specialist

Nusantara Prime Consulting Pte. Ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Nusantara Prime Consulting Pte. Ltd. is seeking a QA Compliance professional in Singapore with 6+ years in GMP manufacturing operations to drive quality, compliance, and data governance across functions.

The role involves audits, inspection readiness, and CAPA support within a collaborative team environment. Responsibilities include training on data integrity, supporting internal and external inspections, and coordinating quality risk management and regulatory submissions.

Qualifications

• At least 6 years QA experience in GMP manufacturing operations (API/Bio manufacturing) and related quality/compliance roles.
• Experience in internal audits and external inspections is preferred.
• Knowledge of data integrity and data governance principles is required.
• Strong knowledge of engineering operations, OT and IT systems (Deltav, MES, SAP, LIMS) and system interfaces preferred.
• High adaptability with ability to lead and collaborate with cross-functional teams.
• Strong written and verbal communication skills; team-oriented mindset.

Responsibilities

• Conduct training for data integrity and review related documentation and risk assessments.
• Perform internal audits and support CAPA follow-up and open CAPAs management.
• Serve as Compliance Partner for inspection readiness for assigned departments.
• Support external inspections (logistics and backroom support).
• Assist other areas (Quality risk management, Quality Plan, QMR tasks, regulatory submissions) with open tasks and document revisions.

Skills

QA Experience

Audit & Compliance

Data Governance

Cross-functional Leadership

Communication Skills

Tools

Deltav

MES

SAP

LIMS

Job description

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