Responsible Person / QA x2 - hybrid Dublin
Location:
Flexibility to work remotely/hybrid with regular onsite attendance at client locations
One of our clients, an award-winning pharmaceutical consulting company, is expanding their dynamic Quality Assurance Department and looking for a RP to join them on a permanent basis.
If you're passionate about quality assurance and compliance in the pharmaceutical sector, we want to hear from you
Key Responsibilities:
* Support the Quality team in maintaining the organisation's Quality Management System (QMS).
* Ensure compliance with ISO 9001, GMP, and GDP standards, as well as internal procedure
* Raise non-conformances, deviations, and change requests, ensuring all trackers are meticulously maintained.
* Manage the supplier controls system, including evaluations and assessments.
* Analyse process performance and prepare presentations for Quality Management review meetings.
* Conduct internal audits and ensure adherence to audit schedules.
* Drive continual improvement initiatives and maintain internal KPIs.
* Communicate changes to the QMS to team members effectively.
Specific Responsibilities for Responsible Person:
* Ensure compliance with GDP and relevant EU/HPRA guidelines.
* Uphold the conditions of the Wholesale Distribution Authorisation, ensuring all medicinal products are handled under strict GDP conditions.
* Conduct timely bona fides evaluations of suppliers and customers.
* Oversee self-inspections and audits according to the audit schedule.
* Serve as the primary contact for the HPRA, reporting changes in facilities or products promptly.
* Prioritise patient and product safety at all times.
What We're Looking For:
* Proven experience in quality assurance, specifically in a pharmaceutical or healthcare setting.
* RP qualification.
* Being named on a Wholesale Distribution Authorisation (WDA).
* Strong knowledge of GDP, GMP, and ISO standards.
* Excellent organisational and communication skills.
* Ability to work independently and collaboratively in a team environment.
* A proactive approach to problem-solving and continuous improvement.