Quality Assurance Officer

AbbVie; Zwolle; On-site; EUR 52,000 - 76,000; Full time

Job summary

AbbVie in the Netherlands seeks a QA Officer to support distribution and logistics quality systems, ensuring compliance with GDP and GMP. You will help maintain policies and support planning and customer service to facilitate compliant shipments.

Join a team focused on continuous improvement of local quality systems, participating in audits and investigations of distribution exceptions, contributing to training and documentation changes.

Qualifications

• Bachelor's degree in life sciences or related field.
• 2+ years of experience implementing and maintaining quality systems in pharmaceutical GDP environment.
• Knowledge of GDP/GMP regulations is an advantage.
• Excellent writing and communication skills in English.

Responsibilities

• Oversee and improve operational processes within the assigned quality system(s).
• Advise staff on GDP/GMP compliance and AbbVie policies.
• Monitor performance metrics and drive improvement programs.
• Maintain documentation per GDP/GMP guidelines and AbbVie policies.
• Support training on good distribution and manufacturing practices.
• Participate in QA projects and continuous improvement initiatives.
• Contribute to change management affecting documentation and procedures.

Skills

Quality systems

Leadership

Analytical thinking

English writing

Regulatory awareness

Education

Bachelor's degree in life sciences

Tools

SAP

TrackWise

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

The QA Officer has an important supportive role in the quality assurance of distribution and logistics operations and to ensure that activities continue to meet the requirements of GDP and GMP regulations.

Contributes to the development and maintenance of the Company quality policies and systems to ensure that business objectives are met for the distribution programs for AbbVie Logistics.

Providing operational support to the planning and customer service department to ensure that shipments are prepared and facilitated in a compliant manner meeting all requirements.

Contribute to the continuous improvement 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 distribution complaints and exceptions.

Highlighted Responsibilities

• 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.
• Maintains the documentation related to the assigned quality system, according to GDP/GMP guidelines and AbbVie policies.
• 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.
• 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.

Qualifications

• 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.
• 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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html