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IT GxP Compliance Specialist

  • Wrocław, dolnośląskie pokaż mapę
  • Specjalista
  • 21.02.2019

    Pracodawca ma prawo zakończyć rekrutację we wcześniejszym terminie.

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    Smith & Nephew is a global advanced medical technology business. We support healthcare professionals in more than 100 countries to improve the quality of life for their patients. Since 1856, when our founder T.J. Smith developed a new method for refining cod liver oil, and in World War One when his nephew led the supply of wound care products, to the present day, Smith & Nephew continues to pioneer health solutions.
     
    Through our market leadership positions in Sports Medicine, Trauma, Orthopaedic Reconstruction and Advanced Wound Management, our 16,000 employees continue to improve outcomes and expand access, constantly striving to create value for healthcare professionals, patients, payers and shareholders.
    IT GxP Compliance Specialist
    Workplace: Wrocław
    Job Description
     
    The IT GxP Compliance Specialist works in the Information Technology Group and reports to the IT Director GRC. Their main role is to insure that the global IT organization is in compliance with all applicable healthcare laws and regulations with a focus on computer systems validation. In order to facilitate these efforts, it is necessary to understand both the global organization and global regulations. The role requires good communication skills to be able to work with a wide variety of IT and non-IT staff at various sites around the world.
    The role is also responsible for coordinating and facilitating internal and external audits of IT. In this role it is necessary to work with auditors in addition to Regulatory, Quality, Finance, IT and other personnel as required.  Post-audit requirements include following up on audit findings and working with the appropriate staff to remediate all findings.
     
    Relationships:
     
    Work and partner with IT and Business leaders, external audit partners/directors and be able to interface directly with senior management when necessary.
    Earn and maintain confidence of their core customers, both inside and outside of the group, to foster teamwork and support the vision and goals of the IT organization.
     
    Responsibilities:
    • 35% Provide consultation and governance in the areas of regulatory requirements and Computer System/Software Validation
    • 30% Coordinate and manage global IT efforts toward compliance with the Quality System Regulation and non-product Computer Software Validation in compliance with regulations such as FDA CFR 21 Part 820 / Part 210 / Part 211 / Part 11 and ISO 13485.   This role includes advising IT and the user community what falls under these regulations and helping to coordinate efforts toward compliance with them
    • 15% Work with internal and external auditors to facilitate all IT components of regulatory audits.  This includes setting up schedules, providing work spaces, acting as the facilitator and escort for audits, and working with global sites to plan and execute audits at individual sites
    • 5% Perform internal and/or external audits of IT sites to insure compliance with IT CSV procedures and applicable regulations
    • 5%  Maintain current knowledge of pertinent regulations.  This is accomplished by attending seminars, subscribing to compliance publications, and working with global staff members in IT, Regulatory, and Quality to understand specific site requirements
    • 10% Support and adhere to all IT policies, procedures and standards, including but not limited to, IT Guiding Principles, Project Management, Change Management, Internal and External Compliance such as Health & Safety, Quality, Regulatory and Finance, and support of Internal and External Audits
     
    Education:
     
    Bachelor’s degree in a Computer, Science, Engineering or related field, or an equivalent combination of training and experience.
    Must be fluent in English, reading, writing, speaking and listening.
     
    Licenses/ Certifications:
     
    Any certifications related to quality systems, GxP and computer systems validation beneficial
     
    Experience:
     
    At least 7 years in Information Technology with at least 5 years of that in supporting and/or managing IT Quality Computer System/Software Validation delivery and oversight. 
    Significant experience of Cloud computing in a healthcare environment, computer systems validation within an Agile environment and the GAMP 5 framework. 
    Experience of IT controls/frameworks such as  Sarbanes Oxley IT General Controls, ISO27000 series, COBIT would be an advantage.
     
    Competences:
     
    Decision Making - Obtains information and identifies key issues and relationships relevant to specific goals; commits to a course of action to accomplish goals after developing alternatives based on logical assumptions, facts, available resources, constraints, and organizational values.  Escalates decisions to next level where resolution cannot be found.
    Building Working Relationships - Developing and using collaborative relationships to facilitate the accomplishment of work goals. Consultative in approach.
    Improvement Focused. Thinks creatively outside the usual boundaries; questions the status quo; initiatives, drives and manages new ideas to achieve the IT vision and goals.
    Gaining Commitment - Using appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behaviour to accommodate tasks, situations, and individuals involved.
    Successful Team member - Supports and works effectively with others, internally and externally, to achieve common goals and objectives.  Using appropriate methods and a flexible interpersonal style to help with the completion of team goals.
    Customer Focus - Making customers and their needs a primary focus of one’s actions; developing and sustaining productive customer relationships.  Passionate about service delivery and meeting the demands of the customer.
    Planning and Organizing - Establishing courses of action for self and others (where appropriate) to ensure work is completed efficiently.
    Engages with technical design and project managers or Project Management Office, to ensure correct products are produced, in a timely fashion. Evaluates the quality of project outputs against agreed service acceptance criteria.
    Conducts formal reviews of activities, processes, products or services. Collects, collates and examines records as part of specified testing strategies for evidence of compliance with management directives, or the identification of abnormal occurrences. Analyses evidence collated and drafts part or all of formal reports commenting on the conformance found to exist in the reviewed part of an information systems environment.
    Supports projects, functions or teams in the development of project and/or operational methods for measurement. Specifies base and derived measures which support agreed information needs. Identifies and prioritises appropriate measures, scales, and targets. Specifies how to collect and store the data for each required measure. Provides guidance on collection of data including automation. Designs reports and reporting formats.
    Conducts formal audits or reviews to ensure compliance with organisational standards for activities, processes, data, products or services. For projects, development or support activities; plans, organises and conducts audits and determines whether appropriate quality control has been applied. Collates, collects and examines records, analyses the evidence and drafts all or part of formal compliance reports. Determines the risks associated with findings and non-compliance and proposes corrective actions. Provides advice and guidance in the use of organisational standards. Performs  quality assurance reviews of suppliers and throughout the supply chain.
    Advises on the application of appropriate quality management techniques and standards. Ensures that projects, teams and functions have appropriate practices in place and are meeting required organisational quality levels. Determines areas where existing processes should change from analysing audit findings. Takes responsibility for controlling updating and distributing organisational standards. Facilitates improvements to processes by changing approaches and working practices, typically using recognised models.
    Actively maintains recognised expert level knowledge in one or more identifiable specialisms. Provides definitive and expert advice in their specialist area(s). Oversees the provision of specialist advice by others, consolidates expertise from multiple sources, including third party experts, to provide coherent advice to further organisational objectives. Supports and promotes the development and sharing of specialist knowledge within the organisation.
     
    Travel Requirements:  <10%  
     
    For this position we offer
    • Private health care | multisport card | life insurance
    • Subsidies for trainings | postgraduate studies
    • Annual bonus | sharesave plan | going extra miles program
    • Subsidized meals and fruits | integration parties
    • Possibility of working remotely | flexible working hours
    • Possibility of growth in the life sciences start-up company
    • Caring, collaborative and courageous business environment
    • Relaxation zones in the modern workplace
    • Company car
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