Senior Quality Specialist

Location: Pancras Square, London

Competitive Salary And Benefits

Close date: 8th December 2024

Introduction to role

Are you ready to take on a pivotal role in ensuring the highest standards of quality in the pharmaceutical industry? As a Senior Quality Specialist at AstraZeneca, you will provide technical and systems support within the marketing company quality function. You will work independently and collaboratively across various functions, frequently communicating with different levels of management, including senior management. Your role will involve carrying out complex technical project work and ensuring compliance with GMP/GDP regulations for drug products, medical devices, and biologics.

Accountabilities

You will be accountable for the effective management of Quality Systems and procedures required to facilitate GMP/GDP Compliance in accordance with United Kingdom regulations and guidelines, as well as AstraZeneca's Quality Management System standards.

What you'll do:

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
• Specialists with accountability for GXP areas are expected to understand the legal and regulatory requirements of their role to maintain the Quality system and continually improve its effectiveness.
• Provide technical/quality support to teams/projects on a day-to-day basis involving consultation on complex quality issues to assess risk and impact on product safety, identity, strength, purity, and quality.
• Act as an advisor to facilitate sound resolution on a wide range of issues with a diverse group of employees from different business units and different AstraZeneca sites as required.
• Demonstrate proficiency with office systems, databases, and other more complex applications and systems.
• Provide timely and detailed assessments to peers and management.
• Demonstrate ability to work independently and in project settings to deliver objectives.
• Keep own knowledge of best practices, industry standards, and new developments in quality management up to date.
• Lead troubleshooting activities to resolve existing problems, make complicated judgments, and anticipate future developments in AstraZeneca’s Quality related needs.
• Manage Quality Standards and expectations across a broad range of services to provide a high-quality, timely, and cost-effective service.
• Ensure optimal performance across the team through supporting individual development plans and applying new tools.
• Employ prepared information to discuss, plan, and help carry out improvement plans, priority setting, investigation reports, quality or performance improvement recommendations. An ability to seek out, collaborate with, and engage customers and stakeholders in the development of solutions is imperative.
• Manage and maintain assigned quality systems as outlined in current job curricula assignments. Examples include Complaints, Issues Management and Recall, Self-Inspections (QMS Self-Assessments), Deviation and CAPA System, Change Management System, Compliance of suppliers and service providers, Management Review Preparation, Contracts and Agreements, Risk Management, Finished Product Importation Activities, GMP/GDP Marketing Company Compliance, Customer Validation and Revalidation.
• Ensure adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Distribution Practice, and regulatory requirements of own work and others' work.
• Ensure that appropriate decisions and escalations are made, taking into consideration all relevant data. Inappropriate decisions could result in a product recall, adverse impact on patient health, non-compliance rating, and impact on license to operate.
• Promote a Quality Culture in the MC.
• Ability to deliver essential GDP/GMP/QMS training as necessary.
• Deputise / act as a delegate to the MCOQ Lead.

Essential Skills/Experience

• Degree level or equivalent experience
• Diploma or certificate in a science related to the work being carried out combined with at least 3-5 years of practical experience
• Experience of Good Manufacturing Practice and/or Good Distribution Practice, and Quality environment is essential
• Strong communication and influencing skills
• Knowledge of Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) regulatory standards
• Experience of building a quality management system

Desirable Skills/Experience

• Understanding of multiple aspects of physical plant, technical equipment, and other elements of facilities management and manufacturing operations
• Post-graduate qualification
• European Languages

At AstraZeneca, we are at the forefront of shaping the future of healthcare. Our unique position as medical leaders allows us to drive innovation across the entire product lifecycle. From advising on R&D investment decisions to leading pre-launch scientific efforts, we are committed to improving patients' lives. Our collaborative environment fosters creativity and rapid progress, making it an exciting place to work. We thrive on change and innovation, using our scientific knowledge and business acuity to make a real impact!

Ready to make a difference, Apply now to join our dynamic team!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Date Posted

28-Nov-2024

Closing Date

08-Dec-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.