QA Officer

Difference makers wanted.

If you want to be a difference maker and, our people are waiting for you. See the difference you can make at AbbVie. We bring our energy and tenacity to work every day, finding new and better ways to help people around the world.

Join us as QA Officer in our Supply Chain Operations Quality Team and have an impact on the availability of medicines to our patients .

Based at AbbVie’s office in Zwolle, the QA officer has an important role in the quality assurance of distribution, and logistics operations and to ensure that activities carried out continue to meet the requirements of the applicable regulations on Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).

Your tasks contribute to AbbVie’s success and the health of the patients who are at the heart of our work. That is where you join us and where you can help us realize our ambitions. Responsibilities include but are not limited to:

• Continuously executes the operational processes related to the assigned quality system(s)
• Advises staff in relation to these systems, on how to execute the applicable activities in compliance with the GxP guidelines, AbbVie policies and other applicable regulations to ensure product quality and patient safety.
• Continuously evaluates the performance of the assigned quality system through performance management (metrics) and initiates and implements improvement programs accordingly.
• Supports and executes training on good distribution and manufacturing practices and based on AbbVie’s principles of quality assurance.
• Participates actively in QA projects and supports Continuous Improvement activities in the organization by participating in project working teams.
• Executes the appropriate change management impacting documentation, training, and quality systems.
• Provides QA support to repackaging/ relabeling/ secondary packaging activities and ensure that product is reviewed and released in compliant manner meeting all requirements.
• Contributes to the continuous improvement and compliance of the local quality system by participating and advising in new documentation change requests of procedures and SOP’s, contributing to internal audits and dealing with the investigation of exceptions.
• Support external quality inspections and audits. Monitors, coordinates and/or executes response to assigned observations and monitoring the completion of associated action plans through our CAPA framework.
• Assures timely implementation of activities, to support business expansion and/or network optimizations associated to new product introductions.
• Execute against our ER’s / Non-Conformities / Deviations / Complaints framework.
• Identify opportunities for Key Performance Indicators (KPI) and Process Indicator (PI) improvements and coordinate the implementation of these changes. Identify root cause trends across the KPI and PI framework and address opportunities for improvement and report to SCQA management.
• Provides input to the Management Review process.
• Act as process owner for some of the key processes for the function, offers innovative ideas and solutions to maximize business opportunities to address challenges in the function. Provides impact with ideas for the larger organization and anticipates and responds to changes.

• Bachelor with relevant specialization, preferably in pharmaceutics, biology or another life science;
• 2+ years experience with implementing and maintaining quality systems in a pharmaceutical (GDP) environment is preferred;
• Knowledge of Good Distribution Practices (GDP) and/or Good Manufacturing Practice (GMP) is considered an advantage;
• Accurate, persuasive, honest, decisive, analytical, result-oriented;
• Excellent writing and communication skills in English;
• Excellent skills in Microsoft Office;
• Preferably experience with working in SAP, or similar ERP system and TrackWise;
• Able to step up and take leadership to own challenges;
• Persistent and resilient when confronted with obstacles – finds the way;

You have a right to work in the Netherlands and live at reasonable distance from our Zwolle office (hybrid working model).

Questions?

Would you like further information before applying? That is quite understandable. Please send your question(s) to Beatriz Samanes, beatriz.samanes@abbvie.com

Agency disclaimer
AbbVie does not accept unsolicited assistance from search firms for employment opportunities. All CV’s / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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