Quality Assurance Officer

Allergan; Zwolle; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

AbbVie is seeking a QA Officer to support the quality assurance of distribution and logistics operations in line with GDP and GMP regulations. You will contribute to the development and maintenance of quality policies and systems to ensure that business objectives are met for the distribution programs.

Providing operational support to planning and customer service to ensure shipments are compliant. You will participate in audits and drive continuous improvement of the local quality system and

Qualifications

• Bachelor-level degree in pharmaceutics, biology or life sciences.
• 2+ years’ experience implementing and maintaining quality systems in a pharmaceutical (GDP) environment preferred.
• Knowledge of GDP and/or GMP is an advantage.
• Strong written and verbal English communication skills.

Responsibilities

• Execute operational processes related to the assigned quality systems.
• Advise staff to ensure activities comply with GDP/GMP and AbbVie policies.
• Monitor performance of quality systems and drive improvement programs.
• Maintain documentation according to GDP/GMP guidelines and AbbVie policies.
• Support and deliver training on good distribution and manufacturing practices.
• Participate in QA projects and contribute to continuous improvement initiatives.
• Lead documentation changes, training, and quality system updates.
• Investigate distribution exceptions and support internal audits.

Skills

Accuracy

Persuasion

Honesty

Decisiveness

Analytical thinking

Results orientation

English writing

Education

Bachelor in life sciences

Tools

SAP

TrackWise

Job description

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