Specialist Quality Standards and Systems (12 months contract)
- Experience Level
- Experienced (non-manager)
At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need phenomenal people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
As the independent second line assurance function for R&D, our mission in Quality Assurance is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.
The QSS Specialist manages technical and logistical services in compliance with document and system standards within the document management system and other systems within the QSS remit. Acts as a point of contact and support related to these systems.
Job Specific General Accountabilities
Procedural Documentation Enablement
- Conducts tasks related to publishing of procedural documentation (PDs)
- Develops and maintains PD accessibility in designated systems
- Collaborates with the Process Owner and for Manage Procedural Documents and Functional Lead for the system
- Interacts efficiently with roles involved in the development of PD such as Process Owners, authors, reviewers or approvers of PDs to achieve understanding and good working practices relative to PD publishing.
System Support and Administration
- Contributes to the implementation and conduct maintenance activities of systems, platforms and processes in the remit of the Quality Standards and Systems team (e.g. clean-up activities in the systems, UAT, property updates).
- Manages user access to the document management system and provides system support.
- On request provides support to our end-users on the use of the systems/platforms within the QSS remit
- Supports audits/inspections in retrieving data from DMS and provides metrics and reports to customers
- Contributes to the development and maintenance of reference materials.
- Analyses the queries from the user community to identify improvement opportunities in reference materials supporting all types of documents in the DMS.
Quality Assurance General Accountabilities
- Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and guidelines
- Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
- Communicates effectively and leads trainings for QA team and stakeholders
- Involved in and may lead the development and/or revision of QA processes, projects and tools
- Mentors QA colleagues
- Degree level education
- Experience in pharmaceuticals or a related industry and a good understanding for business processes within area of accountability
- Excellent analytical, written and oral communications skills
- Confirmed expertise in system administration and information management
- Proficient in written and spoken English
- High ethical standards, credible, operating with absolute discretion
- Strong collaborative, influencing and interpersonal skills - curious to understand business environment
- Skilled at managing & using technology
- Ability to maintain and build professional networks with stakeholders
- Project management (desirable)
- Document Management (desirable)
Next step - Apply today!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.