Expert Automation CSV

Site Name: Belgium-Wavre Posted Date: Jun 7 2022 The role of Expert 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. Job purpose: To provide support, guidance and expertise to ensure the implementation and execution of the Computer System Validation activities for Wavre, Rixensart and Gembloux sites during project definition and executions. You will be working collaboratively with internal and external partners of automation and other project stakeholders. You will take part of the improvement of automation CSV processes and objectives to be more efficient. Your responsibilities: Business support: To be a subject matter expert for the validation strategy, commissioning and qualification of automation projects in Belgium to ensure that all systems, equipment and facilities are properly and efficiently validated in due time. Liaise and provide support and knowledge in Computer System Validation (CSV) activities to Automation, CAPEX and MPUs to guarantee manufacturing processes are designed and executed to ensure Data Integrity and to deliver expected product quality, as well as robust, sustainable operations. Provide strong and lean validation system to the operations in order to improve the overall validation performance during projects. Lead and apply best practices, seek for continuous improvement and ensure application of the right level (risk-based approach) of Computer System Validation. Participate to the definition of computer system validation evolution for Belgium with active support of automation SME team, quality department, automation engineers and aligned with our strategy. Participate to network of expertise in order to promote synergy and harmonization between MPU/SPU. Organize troubleshooting for validation expertise. 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. Review and participate to the improvement of the CSV practises as well as Global and Technical Standards and guidance, to enhance compliance, standardization and simplification. Ensure compliance and readiness for internal and external inspection and 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 8 to 10 years of experience in validation & qualification in pharmaceutical or an equivalent environment (food industry, cosmetic…) Direct experience with GxP regulated environment within major authority jurisdiction (FDA / EU / WHO Audit) Relevant ISPE GAMP5 quality experience, not necessarily within a quality department Experience with validation system, operations and project management Strong knowledge of cGMP and guidelines (FDA, Eudralex, MHRA, PIC/S, GAMP5, ASTM…) French speaker and fluent in English Need to master the key activities related to validation, maintenance, calibration, in the area of expertise. Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong interpersonal and people management skills with demonstrated engaging, empowering and decisive leadership style and well-developed relation building skills to gain trust, credibility and to build a team spirit within the department The person should be autonomous and portray strong leadership skills to be able to influence the validation strategy Substantial knowledge of regulatory, GMP and legal requirements relating to quality and regulatory. Demonstrated impact and influence Good presentation skills *Li-GSK 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. 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. 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