Are you looking for a rewarding career in a market-leading and innovative company?
Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create what is now the second largest influenza vaccine company in the world. With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
IT Compliance Specialist – Infrastructure
We are looking for an IT Compliance Analyst – Infrastructure. This is a new role that is part of the planned IT Compliance organization to support the IT Infrastructure team to ensure compliance with GxP, Data, Privacy, and Financial requirements.
IT Compliance Analyst Infrastructure will be responsible for ensuring IT Infrastructure, platforms, and tools, are in compliance according to their risk profile and the requirements of the Seqirus Computer System Qualification Master Plan. The role will also be providing advice and participation in project team activities with respect to the qualification of new and existing computerized business applications and other software systems.
Principal accountabilities include:
Owner of the IT Infrastructure Qualification Program
Represents the Company as a Subject Matter Expert with 3rd party suppliers.
Support for Global and Local Projects
Provides direction and participate in project team activities with respect to the qualification of new and existing IT Infrastructure, platforms, and tools to ensure compliance with internal and external requirements.
Prepares plans, test protocols and reports in line with cGxP/ regulatory requirements and practices.
Organize and lead testing as required. Act as test manager, as required.
Ongoing Operational Support
Supports the maintenance and ongoing development of SOPs to ensure compliance to relevant regulations including sections 201, 211, 21 CFR Part 11, PIC/s Annex 11
Ensures that infrastructure-related corrective and preventative actions are established, tracked, and trended and that root cause issues are addressed in a timely fashion
Ensures a scientific and risk managed approach to infrastructure qualification is taken
Provides quality oversight to ensure fitness for purpose of IT infrastructure, platforms, and IT Tools.
Supports audits and Inspections as required
Accountable for the timely remediation of all qualification related audit findings related to IT infrastructure, platforms, and IT Tools.
Conducts internal assessments according to procedure
Review/Approval of infrastructure lifecycle documentation
View and approve (as SME) vendor supplied documentation
Guides and approves IT infrastructure Change Controls
A levels or equivalent
Experience working in documentation and records management
Experience working with an EDMS
Experience in a regulated environment preferred
A working knowledge of regulatory expectations (Good Documentation Practices) related to records management
A working understanding of data integrity
A working knowledge of data privacy rules as they relate to records
Expert level usage of MS Word
Intermediate MS Excel and Power Point usage skills
A good working knowledge of Adobe Standard
A working knowledge of basic EDMS workflow principles
Strong attention to detail
Strong ability to organize and prioritize workloads
Ability to learn new EDMS operations
Ability to communicate clearly in written and oral form.
Built on 100 years of experience in influenza, Seqirus is a new global company with an exciting future. It was created in 2015 when parent company CSL Limited acquired the Novartis Influenza Vaccine business and combined it with its own longstanding influenza vaccine operations.Seqirus is currently the world’s second largest influenza vaccine company and a major partner in the prevention and contr...ol of influenza globally. It is a reliable supplier of influenza vaccine for Northern and Southern Hemisphere markets and a transcontinental partner in pandemic preparedness and response.
Seqirus operates state-of-the-art production facilities in the US, UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and commercial operations in more than 20 countries. In Australia and the Asia Pacific region, Seqirus is a leading provider of in-licensed vaccines and specialty pharmaceuticals. It also manufactures and markets diagnostics for immunhaemotology laboratories and is the sole supplier of a unique range of products made in the national interest for the Australian Government, including antivenoms and Q fever vaccine.Seqirus’ parent company CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovative medicines. It operates in over 30 countries with more than 16,000 employees.
We invite you to take a look at the many career possibilities available around the globe and consider building a career that MAKES A DIFFERENCE. Become part of the Seqirus team today!