QA Operations Specialist: GMP & Quality Oversight

NOVARTIS SINGAPORE PHARMACEUTICAL MANUFACTURING PTE. LTD.; Singapore; Vor Ort; SGD 60.000 - 90.000; Vollzeit

Zusammenfassung

Novartis Singapore Pharmaceutical Manufacturing Pte Ltd offers a 15-month CCP for Biomedical Manufacturing Executives/Professional (Attach-And-Train). The role focuses on QA operation support to ensure GMP-compliant manufacturing and successful new product transfers and launches.

The Specialist will perform QA oversight of production records, investigate deviations, manage CAPAs, and support audits. Candidates hold a science/tech degree and meet CCP eligibility requirements.

Qualifikationen

• GMP knowledge and data integrity are essential.
• Ability to interpret regulatory standards and apply quality systems.

Aufgaben

• Provide QA oversight of site operations and ensure compliance with cGxP and regulatory standards.
• Perform QA review of production batch records and exception closure.
• Lead investigations, CAPAs, and deviations with proper documentation.
• Review and approve GMP documents (SOPs, FRMs, QTOs, etc).
• Support inspection readiness and audits by Health Authority and customers.
• Promote continuous improvement and standard workflow processes.
• Support OpEx improvement initiatives and risk mitigation.

Kenntnisse

Quality Oversight

Regulatory Compliance

Data Integrity

Stakeholder Management

Continuous Improvement

Ausbildung

University degree in Chemistry/Pharmacy/Biology/ Biochemistry or equivalent

Tools

GxP Knowledge

QA Documentation

SOPs

Jobbeschreibung

Novartis Singapore Pharmaceutical Manufacturing Pte Ltd offers a 15-month CCP for Biomedical Manufacturing Executives/Professional (Attach-And-Train). The role focuses on QA operation support to ensure GMP-compliant manufacturing and successful new product transfers and launches.

The Specialist will perform QA oversight of production records, investigate deviations, manage CAPAs, and support audits. Candidates hold a science/tech degree and meet CCP eligibility requirements.