QA Systems and Validation Specialist

7 days ago

Dublin, Dublin City, Ireland DPS Group Global Full time

Position Description:

The QA Systems and Validation Specialist will be responsible for:

  • Assessment of changes for GMP compliance in accordance with site change control procedure for facilities, utilities, lab and manufacturing equipment and control system changes.
  • Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems.
  • Ensure all quality systems are implemented/executed in compliance with ICH Q7, Eudralex, 21 CFR and site Quality standards.
  • Provide expertise around validation ensuring compliance with current industry regulations, guidelines and trends. Reviews master and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Including but not limited to:
  • Qualification of premises, equipment and utilities.
  • Laboratory equipment validation.
  • NPI's
  • High level interaction with the various functions on site: Manufacturing, QC, Utilities and Engineering.
  • Participate in other projects as directed by the Quality Systems & Validation Manager.
  • Strong interpersonal, communication and presentation skills are required for this position as well as good time management, multi-tasking and organisational skills.
  • Min of BSc/BEng in Chemistry, Engineering or a science-related discipline with at least 3 years pharmaceutical experience ideally in a QA role. Preferably with experience in change control/documentation management, good manufacturing practices.
  • Knowledge / appreciation of other site operations such as QC, Operations, Engineering, IT.
  • Some experience in Operational Excellence or project management would be desirable.
  • Knowledge of relevant regulatory requirements for Data Integrity, including GMPs.
Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing and Engineering Services

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