Computer Systems Validation Specialist - Waterford - Eirgen Pharma

    Eirgen Pharma
    Eirgen Pharma Waterford

    1 week ago

    Default job background
    Description

    Job Title: Computer Systems Validation Specialist

    Eirgen Pharma is seeking a highly skilled and experienced Computer Systems Validation Specialist to join our team.

    This role will ensure that site automated equipment systems are introduced, maintained and operating in accordance with cGMPs, site and regulatory requirements with a keen focus on Data Integrity, Security and Reliability.

    About the Job

    • Own the policies and procedures in relation to automated equipment systems in terms of defining, implementing and reviewing these, ultimately to ensure compliance with cGMPs, site and regulatory requirements (21 CFR Part 11, Annex 11 EU GMP).
    • Guide/engage team members and external equipment suppliers in relation to validation & compliance activities regarding current and future automated equipment systems (manufacture and facilities, including connections to MES/QBMS/EBR).
    • Support regulatory inspections and internal audits with a focus on 21 CFR Part 11; EU GMP Annex 11, GAMP and Data Integrity requirements.
    • Ensure the automated equipment systems landscape is documented and up to date in terms of additions or retirements, and triggers are in place for periodic activities as required.
    • Engage with cross-departmental teams in authoring specifications, risk assessments, testing protocols, validation reports, standard operating procedures, work instructions, system quality reviews, identifying deficiencies, preparing CAPAs and change controls.
    • Create and act on change Controls, CAPAs and deviations related to automated systems.
    • Ensure periodic audit trail reviews (activities, users, system changes) are carried out.
    • Assist in training end-users as appropriate and relevant.
    • Prioritize, manage, and execute on multiple projects as relevant in relation to additions, retirements or updates/patches/modifications to software or hardware.
    • Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
    • Perform additional team tasks as agreed to support effective running of the Business.
    • Keep up to date with advances in the field, in the areas of regulatory, IT and equipment in particular.

    About You

    You are educated to a minimum of degree level in computer science, computer engineering, life science, or any other pertinent degree. Your experience includes computer systems validation within the Pharma industry and you have extensive knowledge of the validation deliverables associated with each step of the computer system life along with knowledge and proven application of established risk management.

    You also possess cross-functional project experience and exhibit understanding of/interest in IoT (Internet of Things).

    As a positive leader, you will draw from your many skills such as decisiveness, compliance focus, planning, multi-tasking, project and time management. You have the ability to form strong relationships and negotiate and influence cross functionally, you enjoy collaborating, gaining knowledge, continuous improvement and solving problems.



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