Jan 18, 2023

Job Description

AAA Statement

Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Description

40+ is the dedicated number of team members you would be joining at IDB (Advanced Accelerator Applications, Netherlands) whose mission is to bring new therapies to patients wordwide by producing radiopharmaceuticals for targeted radioligand therapy. IDB 's team embraces the culture of empowerment and team work.

The focus of the Technical QA engineer is to provide support to the QA Operations organization with the review and approval of technical QA records and to represent AAA Baarle-Nassau Quality in change control committees, expansion projects etc. This role acts as the main QA contact for user requirements, specifications of production & QC equipment, computerized systems, calibration equipment.

Your responsibilities:

- Review and approve the validation strategy of the site from a QA perspective.
- Support in collaboration with the Site’s Manufacturing science and Technology department (MS&T) the establishment, review and approval of the site’s validation master plan
- Supports establishment, review and approval of maintenance and calibration strategy
- Review and approve validation and maintenance protocols, report and record for the production, warehouse/supply chain and QC department
- Support during inspection preparation and acts as single point of contact for QA validation/calibration and maintenance during audits and inspections
- Act as QA investigator to review deviations or OOx related to validation, maintenance, calibration, and technical production related issues. Ensures the root cause is determined, evaluate the impact on product quality and disposition of the batches
- Ensure compliance with industrial standards and GMP guidelines. Implement preventive maintenance plan in shutdown intervals according to the schedule maintenance plan and planned corrective repairs to equipment problems. Participate in maintenance/reliability reviews of new projects.

Diversity & Inclusion / EEO

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

Minimum Requirements

- Bachelor’s degree or Master’s degree in a scientific area
- Proven experience in validation, maintenance, engineering or technical quality in a pharmaceutical cGMP or medical device environment
- Analytical attitude and eye for detail
- Open and clear teamwork and interpersonal skills
- Knowledge of Word, Excel, Adobe Acrobat

- Good knowledge of English (verbal and written)
- Knowledge of Dutch is a big plus
Full Time
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Technical QA Specialist

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