Principal accountablities include:
Ownership of the IT Infrastructure Qualification Program
- Represents the Company as an Subject Matter Expert (SME) 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 infrastructurequalification is taken
- Provides quality oversight to ensure fitness for purpose of ITinfrastructure, platforms, and IT Tools.
- Supports audits and Inspections as required
- Accountable for the timely remediation of all qualification related audit findings related to ITinfrastructure, 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 ITinfrastructure Change Controls
- Bachelors degree in a scientific or IT based discipline (e.g., Computer Science, Information Systems, etc) or equivalent qualified by experience
- 7+ years experience in an IT Infrastructure role in a GxP regulated environment
- 5+ years experience in IT Quality and /or GxP Computer Qualification
- Experience with change controls, life cycle management, and operations in GxP regulated environments.
- Experience operating with outsourced service providers in an international context
- Proficient in ITIL service management methodologies
- Understanding of the public/private cloud technologies and their qualification approach
- Working knowledge of external control audits (SSA 16 or equivalent)
- Working knowledge of GAMP 5 Systems Development Life Cycle (SDLC) methodology.
- Working knowledge of quality and risk management tools, CAPA and deviation management, documentation management, training, change control and qualification.
- Working understanding of virtual technologies and qualifying them
- Demonstrated ability to think strategically and to work collaboratively using risk-based, proactive approaches to operations problem-solving
- Leadership skills and the ability to manage and work with individuals in a matrixed environment.
- Excellent interpersonal skills and the ability to operate and influence key stakeholders in a dynamic and pressured environment.
- Excellent analytical, written and oral communication skills for both strategic and tactical messages with the ability to translate technical terms and GxP computerized system risks into QA business language with sound rationale.
- Strong project management skills
- Strong team worker with a demonstrated collaborative approach
- Positive and energetic
Share:CityMaidenheadStreet AddressThe Point Level 3PrimaryLocationSeqirus UK - MaidenheadAdditionalLocation(s)Seqirus USA - NC - Holly Springs
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