R&D Lab Computer Senior Specialist

작업 내용

Site Name: Belgium-Wavre

Posted Date: May 23 2022

Job Purpose

As R&D Lab computerized system Senior specialist, you:

• will actively contribute for the definition of network integration strategies for Quality computerized Lab systems, in line with GSK Tech rules and policies, based on business requirements and following QA recommendations.
• manage Lab Systems “Life Cycle Management” plans, with a focus on GxP Compliance / Data Integrity and Cyber Security / OT Standards
• manage internal network of local experts and ensure sharing of best practice and learnings in area of expertise
• for systems used in a regulated (GxP) environment, define and approve, as Technical Owner, the Integration, Configuration and Life Cycle Management for validated systems (more than 250 validated lab systems in R&D Belgium). She/he will lead/ be accountable for activities such as technical Audit preparation, Periodic reviews, Services Catalogue upgrades, Change Management, etc.
• for systems used in non-regulated environment, will define and/or review technical mitigation and remediation strategies, leading to the respect of the Data Integrity principles, by monitoring and assessing industry trends, new solutions on the market, but also evolving regulatory expectations
  

Key Responsibilities

With a high degree of autonomy and in a team of IT-skilled profiles, dedicated to the management of computerized lab systems:

• You ensure for New Equipment Commissioning projects, the definition of landscape design for “computerized system(s)”, in respect to Tech rules, but also to Data Integrity and Cyber Security standards
• You lead integration of complex Client-Server solutions, cross-platforms or cross-sites
• You communicate & share detailed knowledge of best practices & current trends, acquired both internally & externally on Cyber Security Threats and Protection
• You embed Cyber Security into all solutions and ways-of-working along the system’s life cycle
• You ensure the management of service contract
• You are the first point of contact with key stakeholders (internal customers, Tech partners, etc.) for key projects & initiatives and support head of function in priority definition & coordination of activities
• You define plans for “Systems’ Life Cycle Management” aspects, such as:
• Maintenance and Support Model
• “Back-up and Restore” strategy for the data
• “Disaster Recovery” strategy for the system
• Obsolescence management (upgrades, migrations, replacements)
• You review “validation documentation” and other deliverables in the scope of the release and validation of R&D Computerized Systems and act as “Technical Owner” in case of Audits
• You create SOP/WKI and other guidance documents in the field of expertise
• Lab Systems Integration (Tech Infrastructure, Network, etc.)
• Analytical Software Management
• Application of Cybersecurity mitigations and standards
• Data Integrity mitigations and remediations
  

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

• Computer Sciences: Master level or equivalent by experience
• Expertise in defining network integration solutions for computerized lab systems
• Strong experience with Lab and IT activities, advanced knowledge in IT Infrastructure and IT Risks and Compliance aspects
• Experience and advanced knowledge in industry standards and practices, in the field of Cyber Security (International Society of Automation, National Institute for Standards and Technologies)
• Proven experience in the field of analytical lab equipment (GAMP, CFR 21)
• Robust Experience with Quality Assurance in pharmaceutical environment.
• Fluent French and good knowledge of English
  

Preferred Qualifications

If you have the following characteristics, it would be a plus:

• Highly comfortable with working in a diverse, ambiguous and a fast-paced environment.
• Ability to manage Risks, define risk-based strategies.
• Ability to challenge and debate issues.
• Ability to look at situations from several points of view.
• Ability to quickly assimilate facts and data and develop an understanding of complex matters.
• Strong analytical skills with drive to synthesize the story into an actionable set of recommendations
• Assesses needs & constraints and converts these into a realistic solution
  

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022:New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients– so we deliver what matters better and faster; accountable for impact– with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

Li-GSK*

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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