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.
Summary
An exciting opportunity for an individual with an established background in quality and proven ability to drive and develop quality system requirements. The successful candidate will be responsible for ensuring on the delivery of Batch release and that all quality system procedures and processes are effectively implemented.
Working hours are Monday to Friday, 9am - 5pm (with some flexibility)
Essential Duties & Responsibilities
* Co-ordinate the completion of Quality System requirements.
* Be part of investigating events using root cause analysis tools and assisting in driving change through recommendations to correct the event and prevent recurrences.
* Work with other departments to assure timely completion of CAPA's, Change Controls and ensure site KPIs are met.
* Drive a right first-time culture across all departments, working with cross functional teams to drive compliance through the correct implementation of policies, procedures, and practices.
* Participate in scheduled internal and Global Compliance audits.
* To be familiar with GMP, CAPA, Change Control and Training Management Systems and to deliver associated training.
* Actively working on Batch Release workload.
* Proactively identify and support implementation of continuous improvement.
* Maintain and organise the Archive of GMP documentation on and off site.
* Perform other reasonable duties as required for the efficient operation of the QA function.
Education and Experience
* Science based education.
* Ideally a minimum of 2 years’ experience in a GMP manufacturing environment as QA.
* Demonstrated use of lean management tools.
* Knowledge and application of root cause investigation techniques.
* Experience of leading change in own area of expertise and cross functionally.
* Experience in training delivery and training processes.
Benefits
* Competitive total compensation package
* Professional development opportunities
* High importance placed on work life balance
* Commitment to growing and developing an inclusive and diverse workforce
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
Recruitment Fraud Notice
Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
#J-18808-Ljbffr