* My client, a global company with European Headquarters based in
Dublin have a new opportunity for a Senior QA Auditor.
* _YOU WILL_ be part of a dynamic team. The Quality Assurance team
provides support to all sides of their business. Working on complex QA
matters across the business, the QA team delivers on projects
internally and externally.
* The Role
* * Leading on external audits and inspections including scheduling,
preparation, and hosting.
* Supporting inspection readiness activities, including inspections of
external sites.
* To lead CAPA management for external audits and regulatory
inspections where needed, in order to assure responses are compliant
with SOP requirements, Good Clinical Practice guidelines and relevant
regulations, including ensuring appropriate corrective and
preventative actions are put in place and CAPAs are followed until
resolution.
* Preparing root cause analysis on quality issues including ensuring
appropriate root cause analysis, implementation of corrective and
preventative actions and follow-up and effectiveness of resulting
CAPAs.
* Manage inspection readiness activities.
* Lead CAPA management for inspection, where needed, including
ensuring any Inspection CAPA commitments are tracked and followed
until resolution.
* Identify and track required effectiveness checks and ensure
effectiveness checks are completed within the require timelines.
This role will include post COVID travel of up to **Apply on the
website**%.
* What you need
* * Background in medicine, science and/or other relevant discipline
and appropriate experience.
* Thorough knowledge of GCP Guidelines and relevant regulations for
the conduct of clinical trials.
* Experience in hosting external audits and/or regulatory inspections
* Knowledge of CAPA management, including performing effective root
cause analysis
* Experience in regulatory authority inspections an advantage
* Knowledge of medical Device (MDDR) an advantage
* Ability to review and evaluate clinical data / records.
* Excellent communication and interpersonal skills, including the
ability to liaise successfully with project teams, investigators, and
clients.
* Detailed understanding of drug development and clinical trial
process.
* Good problem resolution skills.
* Good planning and organizational skills with the ability to
multi-task and prioritize effectively.
* Ability to work efficiently and independently under pressure.
Show job spec on request.
For full details call Tina at 1 or email your CV to ()
We need : English (Good)
Type: Permanent
Payment:
Category: Others
