Quality Assurance Operations Specialist

Salary Range:

€44,100.00 - €81,900.00

Job Description Summary

#LI-Onsite
Location: Baarle Nassau, Netherlands
We are seeking a detail-oriented Quality Assurance Operations Specialist to join our team in Baarle-Nassau, Netherlands. This role supports a 24/7 shift-based operation, so candidates must be comfortable working assigned shifts, including days, evenings, nights, weekends, and bank holidays as required.

The Quality Assurance Operations Specialist provides QA support for all shopfloor GMP-related activities. The primary focus of the role is to support the timely batch release process and related operational activities, ensuring that batches are released in accordance with regulatory requirements and the local quality system. Responsibilities range from material release and batch record review to deviation support and technical QA support, including activities such as calibrations and interventions

Job Description

Willingness and availability to work on shifts, including days, evenings, nights, weekends, and bank holidays, is required.

Major Accountabilities:

• Prepare and perform QA review of batch release documentation and support the Quality Responsible in the batch release process.
• Provide on-site QA support for shopfloor GMP activities, including interventions, calibrations, and other operational activities.
• Ensure compliant documentation lifecycle management, including review, approval, archiving, and control of paper-based and electronic records.
• Review and release starting materials and incoming goods in accordance with applicable procedures and GMP requirements.
• Review and approve quality-related documentation, including operational procedures, protocols, work instructions, and controlled documents.
• Support deviation, OOS, OOT, OOE, and System Suitability Test failure investigations, including impact assessments, follow-up, and timely closure.
• Support CAPA, action, change control, internal audit, and Health Authority inspection readiness activities, ensuring timely execution of defined actions.

​

Obligatory requirements: ​

• Education: MBO or HBO level, preferably in a scientific, pharmaceutical, life sciences, or related field.
• Solid knowledge of GMP quality systems.
• Basic knowledge of applicable regulatory requirements.
• Strong affinity with and awareness of quality topics.
• Excellent organizational skills with strong attention to detail.
• Ability to work effectively in a team and communicate clearly with cross-functional stakeholders.
• Demonstrates an appropriate sense of urgency and the ability to prioritize tasks in a dynamic operational environment.
• Fluent in English, both written and spoken.

Desirable requirements:

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

Benefits & Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: €44,100 to €81,900.

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

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.

 

Skills Desired