Global QA Product Specialist

4 weken geleden

Weesp, Nederland Abbott Voltijd

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

The Product Quality Specialist supports global strategic products/materials manufactured by Global TPMs and suppliers.

You will be responsible for providing QA general support for assigned TPM’s and quality systems to ensure that safe , efficacious and quality product can be supplied to Abbott to meet cGMP and other applicable regulatory standards and the appropriate market requirements.

Major Duties and Responsibilities: 

Manage assigned Global Suppliers from a Quality perspective.

Provide support to TPM QA Manager in quality relevant product and quality systems requirements.

Provide support for global quality and compliance strategy for assigned commercialized products with global/multiregional scope.

Supports TPM QA manager in planning and execution of major changes for assigned commercialized global products and materials.

Support Co-ordination the change control program for changes impacting products/materials manufactured at assigned TPMs and Suppliers.

Support preparation of Quality/Technical Agreements to align with the legal contracts.

Support a program/project management process to support quality and compliance initiatives at TPMs.

Participate on QA cross-functional teams to support TPMs, as necessary.

Travel to off-site locations to ensure and aid the quality infrastructure and appropriate quality systems for alignment to QA Third Party Manufacturing Quality or Technical Agreements/ or Supplier QTAs.

Support TPM QA manager in the management of critical exception documents and CAPA.

Coordinate and support activities to support TPM QA manager in follow-up on complaint trend investigations for non-medical and medical (adverse events) complaints.

Support TPM QA Manager in review of Annual Product Quality Reports to ensure accuracy, completeness, timeliness, and those trends are identified and addressed in an appropriate manner.

Support the TPM QA management on review of exceptions documents and CAPA’s elevated by TPM’s and ensure that where appropriate senior Quality management are notified.

For assigned TPMs, support TPM QA manager in completing quality review meetings for assigned TPM’s that identify and address quality, operational, and organizational issues.

Support the pre-approval inspection readiness at TPM to ensure regulatory approvals are obtained, with no delays to market entries.

Education and Background:

A 3rd level degree in a relevant Quality or technical/scientific discipline.

Comprehensive understanding of pharmaceutical manufacturing for finished dosage forms with minimum 5 years in QA, Operations, or Technical Support in a pharmaceutical setting.

Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s.

Audit or supplier quality management experience of suppliers in pharmaceutical industry

Troubleshooting and issues resolution skills.

Project management expertise.

Perceptual and analytical problem solving related to removal of obstacles, setting priorities, people, resources and facilities involvement.

Ability to communicate effectively, both orally and in writing to both internal and external audience.

Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.

Ability to use Quality Risk Management tools.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

How do you apply?

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