Senior QA Associate

Senior QA Associate
Job Purpose

Manage IMP release for global clinical studies in Asia and ensure compliance with local regulations and Novartis Quality Manual and Policies.

Key Responsibilities

Support the GDQ (Global Development Quality) Manager and/or NCQ (Novartis County Quality) Head to:

• Manage and Execute QA release for clinical distribution for global studies; complying with the requirements of the Novartis Quality Manual and Policies and meeting all relevant GxP regulatory and legislative requirements.
• Ensure that Standard Operating Procedures are in place for all development and QA related activities and that compliance with GxP regulations is maintained.
• Implement and maintain Quality System for IMP hub related activities in compliance with GxP regulations, Novartis Quality Manual and Policies.
• Monitor and report monthly Key Quality Indicators (KQIs) related to Development and IMP release activities to GDQ Manager/NCQ Head and escalate gaps or non-compliance for risk mitigation.
• Maintain and keep up to date with current local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the GDQ team.
• Collaborate and coordinate with the Global Clinical Supply (GCS) and Global GDQ/TRD QA team for IMP release related activities and address any issues arising from Global Clinical study supplies.
• Support and interact with QA SPOC in Asia countries for any inquiries related to IMP release.
• Act as IMP QA SPOC responsible to provide oversight to IMP regional distribution Hubs.
• Maintain AQWA/Trackwise system and act as QA responsible to perform evaluation on Major/Critical deviations originated at IMP HUB.
• In cooperation with the local NCQ ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.
• Provide development quality support for local development activities.
• Provide support prior and during global internal audits and regulatory inspections.

• Degree in Life Sciences or related fields.
• 2 - 6 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production, distribution or a directly related area.
• Familiarity with GMP or GDP quality systems and procedures/process.
• Familiarity with GCP and system such as SAP, AQWA/Trackwise, Up4Growth and document management system is an advantage.
• Experience in technical writing and quality assessment is an advantage.
• Good communication & interpersonal skills.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas.

In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world.

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Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Pharma QA
Full Time