AstraZeneca Pharmaceuticals LP Quality Assurance Operations in Liverpool, United Kingdom
If you’re passionate about the possibilities of science to change lives and you thrive when making brave decisions – join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every single day. As one of the world’s best-in-class biotechnology companies, our mission is centred on delivering life-changing products that advance world health, and help fight and cure disease.
As a Quality Assurance Specialist, you will be an advocate of good manufacturing practices ensuring quality at source for both manufacturing and Quality control processes, delivering safe and efficacious products to patients on time every time.
Major Duties & Responsibilities
Follow required standards with respect to documentation, good house keeping, cGMP, health and safety, timekeeping, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rulebook, the Code of Conduct, quality manual and any other company policies and procedures.
Take ownership of, and be responsible for, all actions undertaken as part of the role, to ensure commitments to the organisation and colleagues are always met.
Ensure Operational Manufacturing Excellence is integrated into the team’s responsibilities. This should include embracing a philosophy of continuous improvement and a “Right First Time From Me” attitude to all operations. Also promotes cGMP and EHS compliance and Cross functional collaboration.
Supports the generation and delivery of QA functional and operational training, including progression through skills and annual GMP.
Engages with Team Leader to deliver schedule adherence
Resolves deviations and CAPA’s and performs product impact assessment using QRM tools.
Works with Technical specialists to provide solution to areas of negative risk/historical constraint/trends
Planning and execution of individual accountabilities, while seeking opportunities for empowerment.
To represent QA in standing meetings, providing input, updates and guidance
Support Quality Management team requests
Support success of Apprenticeship model and onboarding of any new staff members.
Skills and Knowledge Required:
You will have the ability to work independently, whilst remaining organised and capable of coordinating multiple projects with timely results.
You be knowledgeable regarding the validation and operation of manufacturing processes and analytical methods and associated equipment, facilities, automation and information management systems.
To have strong organisational skills to assure turnaround times are met in support of further manufacturing and final release
To be familiar with product development, manufacturing, quality assurance and quality control systems
Ability to write standard GxP documentation with direct supervision
To have and maintain current knowledge of the laws and regulations affecting the manufacture and distribution of biologic, blood and pharmaceutical products
To possess and exercise excellent communications skills and a proven ability to build and maintain constructive relationships
To demonstrate a commitment to quality and is willing to promote quality standards
Must be able to deliver a range of quality training packages within the UK
Next Steps – Apply Today!
If you want to be considered for this excellent 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.
Competitive remuneration and company benefits apply
MedImmune is an equal opportunity employer. MedImmune will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.