Specialist, QA Systems will join the Document Control Team and, along with other team members, will act as a key point of contact and provide cross-departmental support for a variety of document management systems and processes.
Note this is an on-site role.
Key Duties and Responsibilities:
* Preparation and issuance of controlled documentation to support manufacturing and testing activities
* Development and maintenance of the Documentation Management System
* Provision of training and user support for the Document Management System
* Management of the Document Archive and Record Retention Systems
* Maintenance of other document systems and processes e.g. SharePoint, Periodic Review tracking.
* Delivery of GMP/GDP training
* Participation in the internal and external audit program
* Collection of quality metric data
* Support completion of investigation/CAPA activities as applicable to role
* Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
* Authoring, review and approval of QA-related procedures
Qualifications, Knowledge and Skills Required:
* The successful candidate will hold a BSc in life sciences/pharmacy or similar
* A minimum 1-2 years' Quality experience in a pharmaceutical environment is adventitious
* Working knowledge of cGMP requirements for manufacturing and/or systems and compliance.
* The candidate must be able to work across a team matrix in order to meet accelerated timelines
* The candidate must be able to reprioritise tasks as required to meet changing demands.
What's important to us
* Passion: Our dedication to learning and excellence helps us to deliver exceptional results.
* Innovation: We pursue disruptive and bold solutions for patients.
* Urgency: We move together with speed and quality because patients are waiting.
* Accountability: We all own success and strive to be transparent and deliver on our commitments.
* Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
* Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential.
