LES Lab Support Lead - EU/APAC (m/f/d)
Hays
Bern
vor 19 Std.

My duties

  • Align with the Manufacturing and Quality global business groups and provide strategic direction for LES support teams at each site
  • Interface with Compliance and Digital Quality to ensure principles of Lab management align with company standards and with I&T processes
  • Facilitate cross site communication prior to instrument purchase so that like instruments are procured for similar tasks in the Laboratory domain
  • Engage with site Managers to ensure LES needs are met in a timely manner and manage escalations across sites, monitoring for trends
  • Assist with process improvements involving lab instrumentation and technologies
  • Collaborate with site Managers for efficiency management and continuous process improvement of lab systems, implementing new features, software, or technologies to enhance operational performance
  • Develop standards for Lab builds in coordination with I&T, including hardware, software, antivirus, backup, and patching
  • Ensure new lab projects are scoped, budgeted, and scheduled to incorporate LES requirements, conform to regulatory standards, and utilize LES, I&T and pharmaceutical best practices
  • Create redundancy in lab systems at each site, removing single points of failure
  • Navigate and assist with PMO and Change Control processes for smooth delivery of LES projects
  • Interface with instrumentation vendors for information on new Lab equipment and software
  • Develop BAU budget for each site, incorporating support and routine qualification activities
  • Work with site and global project teams to create annual budget in support of site and global project initiatives
  • Advise on LES financial requirements for large capital or special projects and new site build-outs
  • Plan and prepare for next-generation lab systems through the use of technologies like OS and software virtualization, and be prepared to implement when new technologies are supported by instrument vendors.
  • Engage vendors and other industry professionals to stay up to date on the latest technology, regulatory trends, and industry best-practices and standards
  • Manage team and provide guidance and direction for alignment of business needs, as well as conduct performance evaluations for direct reports, manage contracts for outsourced site support teams
  • Assist Lab Support Analysts in performance feedback of contract staff, train and coach, engaging HR when appropriate. Also explore external education opportunities for teams
  • Recommend additional training and educational requirements as regulatory and business needs change and mature
  • My qualifications

  • University Degree in Computer Science, Information Systems, Business Administration, or other related field or equivalent practical experience
  • Several years of hands on IT Laboratory support and software validation experience
  • Experience working in pharmaceutical / biotech industry and with vendor management and budgeting
  • Knowledge of GAMP 5 framework and SDLC required, as well as GxP, EMA and FDA regulations (including 21 CFR Part 11)
  • Understanding of Project management framework
  • Experience in writing SOPs, Validation Documents, Risk Assessments, Verification plans and test scripts
  • Experience with current Internet technologies / protocols are a plus
  • Experience in Trackwise, GLIMS, EDMS, SDMS, and E-Learning systems
  • Experience in Analytical and Pre-Formulation and Formulation system software
  • Thorough knowledge of Windows desktop and server operating systems, antivirus, Active Directory, storage devices, backup applications, hardware and software virtualization technologies, routers, switches and other solutions
  • Knowledge and support of standard software packages including Microsoft Office and Adobe productivity tools
  • Strong written & verbal communication.
  • Effectively collaborate with peers, cross-functional teams and users across the organization to achieve end-to-end product and process quality
  • Strong Analytical / problem solving skills.
  • Ability to be organized and able to multitask
  • My benefits

  • Reputable international company
  • Gobal outlook
  • About Hays With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential.

    The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers.

    As recruitment specialists with an international network of contacts, we can offer you decisive advantages all completely free of charge.

    Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience. My contact at Hays

    My contact person

    Yves Fabien Deschamps

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