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.

Saving and sustaining lives by ensuring compliance with the technical and regulatory requirements related to the quality of the finished product in the Manufacture of Solutions manufactured in the Baxter Cali plant, ensuring the release of product to the market under compliance with the specifications, procedures and applicable regulatory standards in GMP/GMP, ISO 14001, ISO 13485, ISO 9001, ISO 14971, Resolution 1160 of 2016- WHO Reports 37 and 45, Resolution 3619 of 2013, Decree 4725 of 2005, Resolution 506-2019/MINSA, Resolution 779-2019/MINSA, Supreme Decree 021-2018-SA.

Stay in sync with current regulations regarding health, environment and safety issues defined in CO6001A, regulations and standards applicable to quality, safety in the supply chain, coordinated energy management system and corporate policies related to their position.

Review the technical documentation for the approval of release of batches manufactured by the Baxter Cali plant, verifying compliance with the requirements established by the marketing authorization (Health Registration).

Establish according to the technical review of the documentation (physical or digital), that each of the unitary processes related to the manufacture of the products are in compliance with the procedures, specifications and critical points of the process determined through the risk analysis, in such a way that it is established if the product meets the requirements and can be released for marketing.

Perform the release of the products in JD Edwards software and generate the quality certificates of the finished products to the Quality Assurance Manager and post them in the tool defined for this purpose.

Develop quality management indicators for the release area and generate improvement plans when the indicator is not met.

Maintain updated procedures applicable to the process according to regulatory and corporate requirements.

Attend internal and external audits, ensure the 6's certification of the area.

Provide support to the regulatory area and the Technical Direction regarding the documentation required for the renewal of Sanitary Registrations, sending notification of changes that impact the GMP & GLP certification and other communications required with regulatory bodies for the products and processes carried out by the manufacturing plant.

What you'll bring

Professional graduated as a Pharmaceutical Chemist (in charge of approval and release of chemically synthesized drugs).

Knowledge in applicable regulation for medicines:

(Resolution 1160 of 2016 - WHO Reports 37 and 45, Resolution. 3619 of 2013, PDA, ICH, Resolution 506-2019/MINSA, 779-2019/MINSA, Supreme Decree 021-2018-SA). (Decree 4725 of 2005, ISO 13485, ISO 14971, ISO 11135, ISO 10993)

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Are you ready to be part of our mission ?

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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