CPO GMP Quality Manager

Novartis (Singapore) Pte Ltd; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company based in Singapore is seeking a Quality Assurance Specialist to ensure product quality and compliance with GxP regulations. Responsibilities include monitoring compliance, conducting investigations, and managing quality documentation. The ideal candidate should possess strong skills in quality management, change control, and risk management. The role offers opportunities to drive continuous improvement in processes and ensure the highest standards are maintained within the organization.

Benefits

Inclusive work environment

Personal and professional development opportunities

Community and volunteer engagement programs

Qualifications

• Participating in volunteer/community projects is essential.
• Functional Breadth is required for this role.
• Must be able to collaborate across boundaries.
• Strong Operations Management and Execution experience needed.

Responsibilities

• Ensure compliance with Novartis Quality Manual and relevant GxP regulatory requirements.
• Monitor and conduct self-inspections and QA investigations.
• Manage and approve critical quality issues according to quality norms.
• Lead global quality assessments and manage documentation.
• Assess quality trends and drive continuous improvement in processes.

Skills

Change Control

Continuous Learning

Dealing With Ambiguity

Guideline

Product Release

Quality Assurance

Quality Management

Regulation

Risk Management

Self Awareness

Technological Expertise

Job description

Summary

Assurance that the product quality conforms with specifications and that production activity is compliant with Novartis quality policy and GxP requirements. Ensure that relevant documentation is up-to-date and archived correctly. Ensure “state of the art” GxP know-how and future trends in the field of GxP.

About the Role

Key Responsibilities:

• Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.


• Prepare, review and check the batch documentation for correctness, completeness and safely archive the original documents for the prescribed period and plan, conduct and monitor self‑Inspection schemes for all sections.


• Monitor actions and corrections accordingly.


• Conduct GxP monitoring on all sections, conduct QA investigation for noncompliance, follow up the corrective actions.


• Archive relative documentations and manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual.


• Ensure investigations are correctly executed.


• Decide escalation to Senior Management Level and lead Global Quality Assessments and manage filing accordingly as well as ensure that Change requests, are managed according to the Novartis SOPs from receipt, through to the implementation and closure.


• Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance and maintain access to regulatory and Pharmaceutical authorities in respect to up‑dated GxP ovide latest know how in the field of GxP and other quality related fields.


• Identify repetitive activities and regulatory areas for which SOPs are required.


• Initiate the introduction of SOPs.


• Plan, initiate and monitor basic GxP-training for all employees in regular intervals.

Essential Requirement

• Participating in volunteer / community projects.


• Functional Breadth.


• Collaborating across boundaries.


• Operations Management and Execution.

Skills

• Change Control.


• Continuous Learning.


• Dealing With Ambiguity.


• Guideline.


• Product Release.


• Qa (Quality Assurance).


• Quality Management.


• Regulation.


• Risk Management.


• Self Awareness.


• Technological Expertise.

Languages

• English.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards

Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.