Senior Quality Specialist & RPi

Proclinical is seeking a dedicated Quality Specialist & Responsible Person for Import (RPI) for a Senior position. This role will play a crucial part in overseeing and maintaining the QMS to ensure compliance with GxP standards. The successful candidate will collaborate alongside the Senior Quality Manager to support various quality processes and ensure inspection readiness.

Responsibilities:

• Manage and maintain QMS processes, including deviations, CAPA, and change controls.
• Serve as a Training Specialist, overseeing the UKIE Training Matrix and conducting quality inductions.
• Act as a Subject Matter Expert (SME) for Quality Risk Management and chair risk management meetings.
• Oversee GxP change controls and manage temperature excursions.
• Lead product quality reviews and manage controlled documentation.
• Act as the UK Responsible Person for Import, ensuring local release of imported products.
• Handle product quality complaints and conduct audits.
• Support the Senior Quality Manager in audit risk assessments and schedules.
• Provide support during inspections and audits.
• Complete tasks to support the Quality Department and engage in additional project work.

Key Skills and Requirements:

• Degree in life sciences or equivalent experience.
• Experience in a quality role within the pharmaceutical industry.
• Knowledge of EU Good Distribution Practice and MHRA/HPRA requirements.
• Proficiency in Microsoft Office and excellent communication skills.
• Self-motivated, organized, and detail-oriented with strong problem-solving abilities.
  

If you are having difficulty in applying or if you have any questions, please contact George Kyriacou at g.kyriacou@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.