Manager Automation CSV

Jobinhalt

Site Name: Belgium-Wavre

Posted Date: Jun 28 2022

The role of Manager Automation CSV is a new role that has been announced as part of the Belgium Automation Transformation.

The mission of the team is to drive the vision of automation across the Belgium sites, by leading the definition, implementation and application of Automation Strategy. The team provide dedicated expertise to support to automation operations & deliver transversal projects for Wavre, Rixensart and Gembloux to ensure that all systems, equipment and facilities are properly maintained, safe, reliable and compliant with GAMP.

To manage a transversal team supporting the Operations and Automation teams as well as internal and external partners, in all Computer System Validation (CSV) aspects of their activities. You will be accountable to apply best practices, validation strategies and procedures by ensuring the execution of the operational CSV activities for Wavre, Rixensart and Gembloux sites.

You will be in charge to develop your team capabilities to ensure a central and efficient pool of CSV operational support and will take part to the improvement of automation CSV processes and objectives to be more efficient.

Business Support

Your responsibilities:

• Ensure the full responsibility of the Automation CSV operational team. This includes people selection, coaching, personnel training to the required competencies, contacts with social partners, as well as all daily aspects of a team’s life.
• Manage priorities, schedules and/or initiatives to assure delivery of Operations (Production, Quality, Automation) objectives.
• Partner internally and externally to Automation in support to Operations to ensure Computer System Validation (CSV) activities are executed as expected following validation procedures and regulatory requirements. This includes user requirements, technical specifications, risk analysis, design qualification, commissioning and qualification (FAT/SAT, IQOQ, PQ), …
• Develop group skill sets and knowledge base to meet the needs of a changing environment.
• Provide suitable recommendations/mutual solutions that show measurable improvement and added value to Operations with respect to emerging technology as well as established solutions.
• Participate to network of expertise in order to promote synergy and harmonization between MPU/SPU.
• Lead and apply best practices, seek for continuous improvement and ensure application of the right level (risk-based approach) of Computer System Validation.
  

CSV (Computerised System Validation)

• Expert for automation CSV activities – e.g. Access control, Backup & restore, data integrity, inventory, life cycle ATS/ANS, validation template – DCS & PCS, MES, monitoring, automated systems and new technologies.
• Participate to the improvement of the CSV practises as well as Global and Technical Standards and guidance by giving feedback and field experiences from the CSV operational team to enhance compliance, standardization and simplification.
• Provide adequate support to inspected departments for automation GMP systems qualification, validation, and modification in maintaining their validating status.
  

Why you?

Basic Qualifications

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

• At least 10 years of experience in validation & qualification in pharmaceutical or an equivalent environment (food industry, cosmetic…), including 5 years of team management.
• Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit)
• Experience with validation system, operations and team management.
• Exposure to FDA regulated environments including computerized system validation experience
• Fluent in French and English
  

Preferred Qualifications

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

• Capacity to make independent sound decisions and independently manage priorities
• Strong networking, influencing and negotiation skills to engage a broad community of multi-departmental stakeholders.
• Positive, Autonomous & solution-oriented
• Ability to handle multiple issues and effectively prioritize
• Decision-making abilities
• Manage complexity and deliver long term benefits for the company
  

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness
• 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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