QA Specialist and Responsible Person (RP)

Posted 13 hours 46 minutes ago by Adecco

Permanent
Not Specified
Other
Dublin, Ireland
Job Description

QA Specialist & Responsible Person

Location: Flexible Remote Work

One of our clients is seeking a QA Specialist & Responsible Person to join their dynamic team! 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 procedures.
  • 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
  • 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.

What They Offer:

  • A flexible remote work environment.
  • Opportunities for professional growth and development.
  • A supportive and collaborative team culture.

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.