Quality Assurance

6 months ago

Addlestone, United Kingdom Astellas Full time

**About Astellas**:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

**The Opportunity**:
As a Quality Assurance Specialist at Astellas, your role is essential in further establishing, maintaining, and implementing the pharmaceutical quality management system. You will collaborate closely with various stakeholders to ensure compliance with local, European, and company quality assurance requirements. Additionally, you will act as a deputy Responsible Person as defined in EU GDP guidelines, performing.

Quality Assurance activities on behalf of the Affiliate and ensuring the quality management of third parties. Your responsibilities encompass maintaining the Quality Management System, overseeing deviations and complaints, conducting self-inspections, and preparing for GDP/GMP inspections by Competent Authorities.

**Hybrid Working**:
At Astellas we recognize the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimizing the most productive work environment for you to succeed and deliver.

**Responsibilities**:

- Maintain the Quality Management System by implementing and continually improving QM systems, procedures, and processes.
- Ensure that deviations and complaints are appropriately investigated and CAPA plans are developed where necessary.
- Perform local checks following receipt of certified medicinal product and execute the local “Release for Distribution" for products in accordance with local regulations.
- Check and prepare quality agreements with local country third parties and perform audits of local country third parties as appropriate.
- Act as Deputy Responsible Person in the absence of the QA Lead & Responsible Person, ensuring appropriate standards of GDP and conditions are maintained during product distribution activities.
- Perform Self inspections, prepare for Internal QA audits and Health Authority GDP inspections, assist the Quality Assurance Lead & Responsible Person during these audits/inspections.
- Prepare monthly KPI report, ensure approval of the KPI report by the Quality Assurance Lead & Responsible Person, and submit the KPI report to the QA Sub-region lead.

**Essential Knowledge & Experience**:

- Previous work experience in the pharmaceutical industry
- Fluency in written and spoken English.
- Understanding of EU GDP, EU GMP,
- Prior experience using Quality Management Systems.
- Ability to communicate and negotiate effectively with peers.

**Preferred Experience**:

- Experience in handling regulatory interfaces such as inspections and audits.
- Strong organizational, coordination, diplomatic, negotiation, and communication skills.
- Computer literacy and analytical mindset with good decision-making skills.

**Education**:

- Bachelor’s degree or equivalent

**Additional information**:

- This is a permanent, full-time position
- Position is based in the United Kingdom

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Work Location: Hybrid remote in Addlestone, KT15 2NX

  • Pharmaceutical Assessor

    5 months ago

    Addlestone, United Kingdom Veterinary Medicines Directorate Full time

    The Veterinary Medicines Directorate (VMD) is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) and is responsible for ensuring the safety, quality, and efficacy of veterinary medicines in the UK. **We have a vacancy for a Pharmaceutical Assessor in the Quality Team** This exciting and interesting job puts you at heart...

  • Service Designer

    5 months ago

    Addlestone, United Kingdom Brambles Group Full time

    CHEP helps move more goods to more people, in more places than any other organization on earth via our 300 million pallets, crates and containers. We employ 11,000 people and operate in more than 55 countries. Through our pioneering and sustainable share-and-reuse business model, the world’s biggest brands trust us to help them transport their goods more...

  • Trade Operations Manager

    1 month ago

    Addlestone, Surrey, United Kingdom Eurocell Group PLC Full time

    **Job Title:** Trade Operations ManagerWe are seeking an experienced Trade Operations Manager to join our team at the Eurocell Group PLC. As a key member of our leadership team, you will be responsible for managing our trade branches and driving business growth.**Key Responsibilities:**Manage a team of branch managers to achieve sales targets and operational...

  • uPVC Products Sales and Distribution Leader

    1 week ago

    Addlestone, Surrey, United Kingdom Eurocell Group PLC Full time

    Job OverviewWe are seeking a skilled Trade Branch Supervisor to oversee the daily operations of our trade branch. As a key member of the management team, you will be responsible for maintaining high standards of customer service, managing stock levels, and driving sales growth.In exchange for your hard work and dedication, you can expect a competitive salary...

  • Support Worker

    1 week ago

    Addlestone, Surrey, United Kingdom Avenues Group Full time

    About the RoleWe are seeking a skilled and compassionate Female Support Worker to join our team at Avenues Group. As a Support Worker, you will play a vital role in supporting individuals with learning disabilities, autism, and epilepsy in our community-based settings.Key Responsibilities• Support daily living activities, including personal care and...

  • Trade Branch Operations Manager

    1 week ago

    Addlestone, Surrey, United Kingdom Eurocell Group PLC Full time

    About the RoleEurocell Group PLC, a leading supplier of uPVC products in the building industry, is seeking an experienced Trade Branch Supervisor to join their team. As a key member of the management team, you will be responsible for overseeing the day-to-day operations of the trade branch, ensuring seamless sales and distribution processes.In this permanent...

  • Catering Assistant

    6 months ago

    Addlestone, United Kingdom Lexington Catering Full time

    Lexington is an award-winning contract caterer that focus on providing great food and service to customers. To do this we need fabulous people and we work hard to create an environment where our team members feel engaged, inspired, valued and enjoy what they do. **Job Description**: **Responsibilities** - Ensure the kitchen and service area are always...

  • Senior Culinary Operations Manager

    1 week ago

    Addlestone, Surrey, United Kingdom Sodexo Full time

    Culinary Excellence at Sodexo As a Head Chef at Sodexo, you will play a pivotal role in shaping exceptional dining experiences for our clients. Located at the Astellas Group site, you will oversee the creation of high-quality catering services that meet the company's exacting standards. Key Responsibilities: Deliver outstanding catering services, meeting...

  • IT Procurement Director

    1 month ago

    Addlestone, Surrey, United Kingdom Brambles Group Full time

    Brambles Group is committed to delivering significant contributions towards its growth goals, enabling markets to win through procurement using breakthrough category strategies and sourcing execution to support operating margin improvement and competitive advantage.Key Responsibilities:Drive value through ensuring the commercial elements of spend in complex...

  • Retirement Living Lodge Operations Manager

    3 weeks ago

    Addlestone, Surrey, United Kingdom Churchill Estates Management Ltd Full time

    About the RoleWe are seeking an experienced and skilled Lodge Manager to join our team at Churchill Estates Management Ltd. As a Lodge Manager, you will be responsible for the day-to-day management of our retirement development, ensuring the well-being and satisfaction of our residents.Your key responsibilities will include organising activities,...

  • Retirement Living Lodge Manager

    3 weeks ago

    Addlestone, Surrey, United Kingdom Churchill Estates Management Ltd Full time

    About the RoleWe are seeking a skilled and experienced Lodge Manager to join our team at Churchill Estates Management Ltd. As a key member of our staff, you will be responsible for ensuring the smooth day-to-day operation of our retirement development.Key responsibilities include:Managing the maintenance of the property and providing a first-class service to...

  • Environmental Sustainability Specialist

    3 weeks ago

    Addlestone, Surrey, United Kingdom Allen & York Ltd Full time

    Allen & York Ltd is seeking a highly skilled and experienced Environmental Consultant/Project Manager to lead our environmental projects. In this role, you will be responsible for managing multiple projects, ensuring they are completed on time, within budget, and to the highest standards.Key Responsibilities:Manage multiple environmental projects, ensuring...

  • Tax Compliance Expert

    2 weeks ago

    Addlestone, Surrey, United Kingdom Brambles Full time

    CHEP, the world's leading supply chain logistics company, is seeking a highly skilled Tax Compliance Officer to join our team in Weybridge. This exciting opportunity offers a hybrid work model, allowing you to balance your time between the office and remote work.As a Tax Compliance Officer at Brambles, you will play a critical role in ensuring the accuracy...

  • Senior Care Service Coordinator

    2 weeks ago

    Addlestone, Surrey, United Kingdom Home Instead Full time

    About UsHome Instead is a leading provider of home care services, dedicated to delivering exceptional support to our clients and their families.Job SummaryWe are seeking a highly skilled and compassionate Field Care Supervisor to join our team. In this role, you will be responsible for overseeing the delivery of high-quality care services to our clients in...

  • Female Support Worker

    6 months ago

    Addlestone, United Kingdom The Avenues Trust Group Full time

    Avenues is a community where people smile, laugh, grow and achieve great things. We know that well-supported people support people well to do their very best for the people we support and achieve our vision. Are you are looking for your next social care role, or a change in career and a feel-good reward? If so, then we would love to hear from you! - Support...

  • Ambulance Care Assistant: Providing Patient Transport Services

    4 weeks ago

    Addlestone, Surrey, United Kingdom EMED Group Full time

    About the Role: We are seeking an Ambulance Care Assistant to join our team at EMED Group, the largest Patient Transport and Care Partner to the NHS. As an Ambulance Care Assistant, you will play a vital role in providing patient transport services to our local communities.Key Responsibilities:Transporting patients to and from medical appointments and...

  • Support Worker

    6 months ago

    Addlestone, United Kingdom The Avenues Trust Group Full time

    Avenues is a community where people smile, laugh, grow and achieve great things, we know that well-supported people support people well, which makes them want to do their very best for the people we support, and achieve our vision. If you are looking for your next social care role, or a change in career, long-term stability, career growth and a feel-good...

  • Portfolio Operations Lead

    6 months ago

    Addlestone, United Kingdom Astellas Pharma Europe Full time

    **About Astellas**: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and...

  • Support Worker

    2 months ago

    Addlestone, United Kingdom CV-Library Full time

    Avenues is a community where people smile, laugh, grow and achieve great things, we know that well-supported people support people well, which makes them want to do their very best for the people we support, and achieve our vision.  If you are looking for your next social care role, or a change in career, long-term stability, career...

  • Tax Compliance Specialist

    1 month ago

    Addlestone, Surrey, United Kingdom Brambles Limited Full time

    CHEP, a pioneering and sustainable business model, helps move more goods to more people, in more places than any other organization on earth via our 300 million pallets, crates, and containers. Our clients trust us to transport their goods more efficiently, safely, and with less environmental impact. Job DescriptionTax Compliance Specialist Full-time,...