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Analyst Quality Assurance

Analyst Quality Assurance

PerrigoDublin, IE
20 days ago
Job description

Description Overview

Scope of the Role

  • Represent QA in computer system validation projects including change controls, deviations and periodic reviews and Data integrity for CSCI
  • Provide support with guidelines and regulations such as GAMP 5, EU GMP Annex 11, and FDA CFR Part 11
  • Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Perrigo CSCI group
  • Keep going awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD).
  • Support in the maintenance of Quality Systems, including electronical systems (Trackwise, LMS,…).
  • Provide QA training to the entire group (European branch of the Perrigo Company) regarding computer system validation and Data Integrity and evaluate training effectiveness, including the creation of powerpoint presentations, online recorded trainings, etc.
  • Ensure adherence to critical procedures and compliance to requirements for record retention.
  • Be part of third-party qualification and regular third-party auditing for all topics related to Computer System Validation and Data integrity.
  • Assist in performing internal QA audits.
  • Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions. related to Computer Systems and Data Integrity
  • Provide support in establishing and maintaining the ISO 9001 and ISO 13485 Quality Management System related to Computer Systems and Data Integrity.
  • Identify gaps and areas for improvement in QA processes related to Computer system and handling and lead remedial actions and initiatives.

Experience Required

  • Bachelor degree in IT, engineering, biochemistry, chemistry or equivalent through experience.
  • You are fluent in spoken and written English, other languages are a benefit.
  • At least 2-5 years relevant experience in Computer system validation in Pharmaceutical and / or Medical Devices industry
  • Deep knowledge of FDA regulations (especially CFR Part 11), EU GMP Annex 11 and GAMP 5.
  • Knowledge of the relevant European regulations for pharmaceutical products (GMP specifically Annex 11, GDP), Medical Devices (MDR, MDD, ISO13485, ISO14971), Food, Food Supplements (HACCP, ISO 22000) Cosmetics (ISO 22716) is an asset

    • Benefits

    We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about at Perrigo. Hybrid Working Approach

    We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more Applicants please note :  To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo

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    Quality Assurance Analyst • Dublin, IE