QA-II

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Ensure Quality System processes are correctly implemented on site to meet requirements for new product development and lifecycle management for drugs and medical devices including ICH, 21 CFR, EMA, ISO 13485 and 14971, MDR.Ensure Quality System processes are correctly implemented on site to meet requirements for pharmaceutical product testing and release.

Review documentation for accuracy and compliance with procedures and release or reject as appropriate (essentially analytical methods development/validation/transfer, stability studies, Design & Development).

Provide Guidance on maintenance of product Design History Files and Risk Man

Must have strong communication oral/written skills, ability to negotiate; and willing to participate in team activities.

Individual must be well organized, pay meticulous attention to details, and be customer focused with strong interpersonal skills. Ability to work with minimal supervision.

Compliance knowledge in the areas of therapeutic / device product development, laboratory control, change control, CAPA.

Analytical method development/validation, laboratory activities or stability studies is an assetagement Files according to relevant Quality System and other regulatory requirements for therapeutics and medical devices.

Interface with Research & Development, Regulatory Affairs, Manufacturing and other disciplines to represent QA in project teams, with the objective of assure that the project quality objectives are met.

Act as QA Approver for Laboratory Out of Specification (OOS), for Quality System Change Controls (CC) and drive Non-conformance or /Corrective Action Preventive Action CAPA).

Comply with Vantive Quality and Environmental Health and Safety policy.

Provide oversight and support lab qualification, analytical instrument qualification and test and validation methods.

Individual must be well organized, pay meticulous attention to details, and be customer focused with strong interpersonal skills. Ability to work with minimal supervision.

Compliance knowledge in the areas of therapeutic / device product development, laboratory control, change control, CAPA.

Analytical method development/validation, laboratory activities or stability studies.

Education: University degree in Engineering or in Sciences (Pharmacy, Chemistry, Biochemistry or Chemical Engineering).

Experience: 7 to 10 years in R&D of Pharmaceutical industry per EU and/ or FDA requirements (GLP/GMP/ISO 13485 regulation).

Experience in Durg development, Therapeutic Goods and GLP environment for conducting the non-clinical R&D studies. Experience in Quality Initiatives (processes, systems, improvements) is a must.

Reasonable Accommodation

Vantive 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. Form Link

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