CSL Plasma
QA IT Manager
At a glance
Location: US-NY-Liverpool Map
Posted: 10/09/2021
Closing: 11/08/2021
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
CSL Plasma
Job description
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

The role of the QA IT Manager is to provide QA oversight for all IT systems in Seqirus Liverpool.

Role to encompass process automation, laboratory equipment, e-compliance, site systems such as SAP, GLIMS and Sentry and will be QA point of contact for IT projects

e-Compliance – ensure GMP critical computer systems are implemented and maintained in accordance with GAMP5 guidelines. eg GLIMS, SAP, Sentry etc.

Integral member of the QA team – able to flex to provide assistance to other QA Managers when required

Maintain site QA oversight of IT Quality Systems, i.e. changes, incidents and CAPA actions

Maintain QAGs, where applicable, with third party IT service providers

Automation – Provide QA oversight for process automation systems such as PCS, MES and OSiPi. Be key contact for compliance of Automation department and provide guidance around changes and sustaining the systems in a compliant manner

Identify and coordinate the Quality focused management of risks associated with electronic projects and life cycles changes, including escalation to site QO management potential quality impact of risk of automation systems at the Liverpool site to enable timely address and mitigation as required.

Lead Data Integrity compliance for the Liverpool site for hybrid systems in Liverpool. Provide oversite of data integrity requirements and how manual controls have been implemented where the systems do not meet the required standards

QA GLIMS oversight of process for administration of passwords, training and compliance of system. Responsible for QA oversight of approval of LRF’s for system updates and changes.

Responsible for ensuring all stand-alone equipment is updated and documented in accordance with summer and winter GMT.

Knowledge, Skills & Competencies

Experience of GMP systems, multiple IT applications and an understanding of QA in a GMP environment is essential.

Validation background preferential

Ability to work with, influence and communicate to key stakeholders and technical operations.

Proven ability to self-manage and prioritisation among a large number of competing tasks

Education Requirements

Ideally candidate to be a post-graduate in relevant degree.

Knowledge of GAMP5 and CSV is essential for the role

Experience Requirements

Experience of GMP systems, multiple IT applications and an understanding of QA in a GMP environment is essential.

Validation background preferential

QA IT Manager