Quality Assurance and Validation Specialist

5 days ago


Dublin, Dublin City, Ireland DPS Group Global Full time
Job Summary

We are seeking a highly skilled professional to fill the position of Lead Validator for Pharmaceutical Systems at DPS Group Global. The successful candidate will be responsible for leading the validation of computer systems, ensuring compliance with regulatory requirements, and collaborating with various functions on site.

Main Responsibilities:
  • Qualify computer systems in accordance with ALCOA+ Data Integrity and Compliance Assurance principles.
  • Assess changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab, and manufacturing equipment and control system changes.
  • Laboratory equipment validation and NPIs.
  • Review and approve GMP design aspects of major capital projects including software upgrading, qualifying/validation recipes.
  • Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR, and site Quality standards.
  • Provide expertise in validation ensuring compliance with current industry regulations, guidelines, and trends.
Requirements:
  • BSc/BEng in Computer application/Engineering or a science-related discipline with at least 4-5 years pharmaceutical experience ideally in a CSV role.
  • Experience leading projects with a small team (1-2 people).
  • Knowledge/appreciation of other site operations such as QC, Operations, Engineering, IT.
  • Some experience in Operational Excellence or project management desirable.
  • Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
Why Work with Us?

This role offers an exciting opportunity to work in a dynamic environment, contributing to the success of DPS Group Global. As a Pharmaceutical Validation Expert, you will have the chance to develop your skills and expertise in a challenging and rewarding role.

Seniority Level:

Mid-Senior level

Employment Type:

Full-time

Job Function:

Engineering and Science

Industries:

Architecture and Planning


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