Quality Assurance Operations Specialist

NL42 (FCRS = NL042) IDB Holland BV; Baarle-Nassau; On-site; EUR 34,000 - 82,000; Full time

Job summary

Novartis in Baarle Nassau, Netherlands is seeking a detail-oriented QA Operations Specialist to support a 24/7 shift-based GMP environment. This on-site role focuses on on-time batch release and QA activities to ensure regulatory compliance and proper documentation.

You will perform batch release reviews, provide site QA support, manage document lifecycles, and assist with deviations, CAPAs, and internal audits. Rolling shifts including days, evenings, nights, weekends, and holidays are required.

Qualifications

• Education: MBO/HBO level, preferably in a scientific field.
• Solid knowledge of GMP and basic regulatory requirements.
• Strong organizational skills with attention to detail.
• Fluent in English, both written and spoken.

Responsibilities

• Prepare and perform QA review of batch release documents and support the batch release process.
• On-site QA support for operational activities including interventions.
• Ensure proper document lifecycle management (paper and electronic systems) and archiving.
• Support deviation management and investigations related to OOS/OOT/OOE and CAPA actions.

Skills

Collaboration

Communication

Data Integrity

Dealing With Ambiguity

Digital Savviness

Leadership

Operational Excellence

Problem Solving

Regulatory Knowledge

Education

MBO/HBO level in scientific field

Job description

Salary Range: €44,100.00 - €81,900.00

Job Description Summary #LI-Onsite

Location: Baarle Nassau, Netherlands

We are seeking a detail-oriented QA Operations Specialist to join our team. This position supports a 24/7 shift-based operation, so candidates must be comfortable working assigned shifts, which includes days, evenings, nights, weekends, and bank holidays as needed.

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).

Job Description Please note: This is a 100% on-site position and is not eligible for remote or hybrid work. Candidates must be available to work within a 24/7 shift schedule.

Major Accountabilities

• Prepare and perform QA review of batch release documents and supports 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).
• Ensures archiving of batch documentation.
• Release of starting materials and incoming goods.
• Perform Visual Monitoring on Surprise on-site inspections.
• Approve and review quality related documentation (operational procedures, protocols, and work instructions).
• Supports with deviation management.
• Ensures that the appropriate impact assessments are performed in a timely matter.
• Ensures that deviations are closed in a timely matter.
• Review and approve the investigations in case of analytical results out of specification (OOS), out of trend (OOT), out of expectation (OOE) or System Suitability Test failures.
• Supports with CAPA’s and Actions and timely execution of defined actions.
• Supports with change controls and 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.
• Experiences: 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 details.
• Shows the appropriate sense of urgency around given tasks, work in team.
• Languages: English fluently, verbally and in writing.
• Work in shifts

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.

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

Learn about all the ways we’ll help you thrive personally and professionally.

Skills Desired

• Collaboration
• Communication Skills
• Data Integrity
• Dealing With Ambiguity
• Digital saviness
• Leadership
• Operational Excellence
• Problem Solving Skills
• Regulatory Requirements knowledge

Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives.