Audits & Supplier Quality Management Support Specialist
At Organon in Cramlington, UK, we are looking for Audits & Supplier Quality Management Specialist.
- Maintain approved supplier list via Supplier Transparency.
- Initiate and maintain Quality Agreements.
- Support oversight of supplier complaints.
- Support oversight of supplier change notifications.
- Provide API and key bulk supplier audit report oversite to QPs on a periodic basis.
- Support Supplier Quality Management (SQM) and Development & Performance Management (SD&PM) groups as required to monitor and address supplier issues.
- Train and qualify as a lead site walk-through auditor and perform walk-through audits throughout the facility as required by schedule.
- Effectively communicate walk-through audit results to stakeholders and site leaders
- Evaluate root cause analysis, CAPA responses, monitor CAPA completion, and verify CAPA effectiveness for Walkthrough Audits.
- Support Internal Audits as required
- Support the preparation and hosting of Health Authority inspections, Customer Inspections and Global GMP Audits as required
- Participate in change and process initiatives related to audits, inspections, and CAPA
- Supports and continually enhance the ongoing site Permanent Inspection Readiness status
- Generation of communication for Site (Quality Council), metrics for audits, inspections, and CAPAs; propose any remediation required and generation of annual audit/inspection performance report.
- Support Data Integrity in line with Topic 3.2 Data Governance and CGMP/CGDP Documentation including visibility of the execution of site Data Integrity plans and shopfloor activities.
- Experience in the pharmaceutical industry preferred.
- Good written and spoken communication skills and ability to lead cross-functional teams.
- Ability to form good working relationships with other functional groups.
- Attention to detail and well-organised approach to working.
- Degree in Chemistry, Pharmacy or other scientific statistical discipline is preferred.
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
Search Firm Representatives Please Read Carefully
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Flexible Work Arrangements:Not Specified
Valid Driving License:Yes
Number of Openings:1