QA Specialist & Responsible Person - hybrid Dublin

QA Specialist & Responsible Person - 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.