Quality Assurance, Trading Party
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Astellas’ Global Capability Centres - Overview
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment
GCC POLAND: This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Responsible Flexibility Guidelines Statement - At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- As a Quality Assurance, Trading Party, you will be responsible for independently completing standard quality assurance activities as well as complex and non-standard quality assurance activities for the Trading Party QA. You will support the Responsible Person, where applicable, and the QA Lead to meet his/her Responsibilities and Accountabilities.
Role and Responsibilities
- Performs and records all activities that are governed by Good Distribution Practise Guidelines (GDP Guidelines) and Good Manufacturing Practise Guidelines (GMP) as defined in the Trading Party Quality Management System (QMS) (for example on QA oversight of outsourced Product Storage and Distribution activities, nonconformance management, product complaint handling, change control, supplier management and annual product review) and identifies and implements improvements to the QMS to correct inefficiencies and nonconformances
- Supports with inspection management for the wholesale dealer license (or equivalent license), specifically during inspections and recalls
- Represents Trading Party QA in complex local and global project teams, such as product launches
- Acts as QA representative for complex and urgent QA activities such as potential recalls, significant quality issues and urgent changes when QA Lead is not available
- Contribute to ensure accurate and timely records are held with relevant parties (qualitative, quantitative information and audit trail) Acts as a role model for the Quality Culture in Trading Parties.
Required Qualifications
- University degree in a science/health-related subject or equivalent.
- Substantial relevant years of experience in a comparable role in the pharmaceutical industry.
- Significant experience of implementation and understanding of GDP, GMP and Quality Management Systems
- Fluency in written and spoken English
- Good organizational, coordination, diplomatic, negotiation, presentation and communications skills
Preferred Qualifications
- Experience with Trackwise (Digital), Veeva and SAP systems
- Experience in supporting regulatory interfaces such as inspections and audits
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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