Specialist, Quality Assurance

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.

• To perform internal quality audits to ensure compliance to all systems and procedures and ultimately build the quality focus and ensure appropriate CAPA is placed.
• To ensure that system and facilities comply as per the regulatory requirements and expectations.
• To ensure cGMP compliance status of site as per regulatory requirements.
• To ensure and sustain all time ready plant in line with current regulatory expectations for regulatory authorities and other partner inspection.
• To verify process and systems are complying with standard operating procedures (SOPs) and current regulatory requirements and expectations.
• To ensure that audit observation compliance and effectiveness of CAPA.
• To perform review of operations and report in case of any non-conformance observed.
• To perform periodic assessment of the GMP trends.
• To perform the assessment of regulatory intelligence program and global observation certification.
• To ensure that the required initial and continuing training of personnel is carried out and adapted according to need.
• To impart training to personnel regarding enhancement in system, and processes.
• To handle electronic QMS modules for review and approval of changes, procedures etc.
• To ensure that data integrity is maintained at all level and to perform / get performed regular checks to ensure that system is in state of control.
• Support product surveillance team in coordinating with Marketing team for sample submission issues or any other unresolved issues.
• Coordinate with sales and marketing team if any significant issues arise.
• Trending of significant issues and escalation, evaluating issues and working out for various actions.

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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