At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.
Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca's priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events.
What you'll do:
The Supplier Quality Principal Compliance Specialist is responsible for Supplier Management at the West Chester site in addition to locally managed West Chester Suppliers. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: change control, supplier complaint and deviation investigations, quality issue management and product release, QA Agreements (establishment and maintenance) between AZ and External Suppliers.
Essential for the role:
- Lead all supplier management compliance programs and lead/execute required compliance activities to ensure the site meets current GMP requirements of local/global regulations and internal AZ quality and compliance policies.
- Drive continuous improvement efforts through monitoring/evaluation of site systems & processes against current compliance requirements and influencing key stakeholders on recommended compliance improvements.
- Quality Investigations (Deviations, Supplier Complaints)
- Responsible for quality issues and resolutions at Suppliers to ensure right product at the right time is delivered into the Product Supply Chain.
- Proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).
- Develops and maintains effective business relationships with Suppliers.
- Provide compliance expertise to the site, collaborating with customers and helping to identify compliance gaps, recommending compliance improvements or solutions for the supply site.
Desirable for the role:
- Bachelor's degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering.
- 7 years of experience in the pharmaceutical industry
- Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role.
- Strong demonstrated knowledge of cGMPs, Quality systems and the pharmaceutical supply chain environment. Also, strong understanding of industry standards such as Pharmacopeia, ISO standards, and so on.
10+ years in QA/Regulatory Compliancein the pharmaceutical industry.
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.Find out more on Social Media:LinkedIn https://www.linkedin.com/company/1603/Facebook https://www.facebook.com/astrazenecacareers/Instagram https://www.instagram.com/astrazeneca/?hl=enAbout Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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