QP Delegate

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

RESUME DE LA FONCTION

Act as QP delegate and as reference quality contact for external contract manufacturers.

Assure that release of Therapeutic Products is in compliance with the legal requirements, altogether with the

satisfaction of the business needs.

TACHES GENERALES

• Be responsible of the final release disposition of therapeutic products, for worldwide distribution in a strict compliance with the GMP, local SOPs and with the regulations from the various National Authorities

• Ensure timely release of the products within the given frame by follow up with internal and external departments (Purchasing, QA reception, logistics, manufacturing, QA laboratories …)

• Final release of the batches by issuing appropriate documents (test certificate, certificate of compliance…)
• Autonomy in review of batch file’s documents, taking responsibility in solving issues related to a file, contacting necessary persons to resolve issues, Initiate batch related investigations, as required.
• Communication with internal and external clients and customers
• Resolve difficulties the team is facing, helping out in order to meet the target
• Keep the procedures related to the release activities up to date.
• To be the reference quality contact for external contract manufacturers
• Review impact of process deviations/exceptions on the quality of the finished product
• Assist in the compilation and review of Annual Product Quality Reviews
• Assumes responsibility of the Deputy Responsible Pharmacist and acts as back up for Responsible Pharmacist in its absence
• Participate to internal and external inspections
  

PROFIL RECHERCHE

• Master’s in pharmaceutical sciences and/or in Industrial Pharmacy

• 5-10 years of experience in a pharmaceutical industry or ISO/GMP approved environment

• Fluent in English and French
• Dedication to Quality. Knowledge of GMP/ GDP and QP responsibilities
• Excellent knowledge of Quality Systems and Manufacturing Processes
• Good and effective communication skills
• Team spirit minded.
• Dynamic and motivated.
• Is very well organized, has an analytical and critical mind, is results oriented.
• Ability to work in a changing environment.
• Accountable and integer

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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