Quality Assurance Operations Specialist

Novartis; Noord-Brabant; On-site; EUR 50,000 - 70,000; Full time

Job summary

Novartis is looking for a Quality Assurance Operations Specialist in Noord-Brabant, Netherlands. The role involves providing QA support for GMP related activities, focusing on the batch release process and ensuring regulatory compliance.

The ideal candidate will have a scientific education (MBO/HBO level) and solid knowledge of quality systems. Tasks include document reviews, quality support for operations, and managing deviations. Fluency in English is required. Join us to contribute to an inclusive work environment while maintaining the highest quality standards.

Qualifications

• Solid understanding of GMP regulatory requirements.
• Experience with quality issues and management.
• Good communication skills in English.

Responsibilities

• Prepare and perform QA review of batch release documents.
• Provide on-site quality support for operations.
• Manage document lifecycle and ensure proper archiving.
• Release starting materials and conduct inspections.
• Approve quality documentation and support deviation management.
• Contribute to audits and inspections preparation.

Skills

Knowledge of quality system (GMP)

Organizational skills

Attention to detail

Sense of urgency

Teamwork

Fluent in English

Education

MBO/HBO level in a scientific field

Job description

Summary: The Quality Assurance Operations Specialist provides QA support for all shopfloor GMP related activities. The main focus is linked to the on‑time batch release process and all related operational activities to ensure that the batches are released according to regulatory compliance and the local quality system. This ranges from material release and batch record reviews, to deviation support and technical QA support (e.g. calibrations, interventions).

About The Role

Major Accountabilities

• Prepare and perform QA review of batch release documents and support the Quality Responsible with the batch release process.
• On‑site Quality support for operational activities including interventions.
• Guarantee the correct document lifecycle management (paper and electronic system). Ensure archiving of batch documentation.
• Release of starting materials and incoming goods.
• Perform visual monitoring during surprise on‑site inspections.
• Approve and review quality related documentation (operational procedures, protocols, and work instructions).
• Support deviation management ensuring that the appropriate impact assessments are performed in a timely manner and that deviations are closed in a timely manner.
• Review and approve investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE), or System Suitability Test failures.
• Support CAPA’s and actions, and ensure timely execution of defined actions.
• Support change controls and ensure timely execution of defined actions.
• Support the preparation and execution of internal audits and health authorities inspections.

Obligatory Requirements

• Education: MBO/HBO level, preferably in a scientific field.
• Experience: Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements.
• Strong affinity with and awareness of quality issues.
• Good organizational skills including attention to detail.
• Shows the appropriate sense of urgency around given tasks and works well in a team.
• Languages: English fluently, verbally and in writing.

Desirable Requirements

• Optional: Experience with radiation, PET or radiopharmaceuticals is highly valued.

Commitment To Diversity And Inclusion

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