Sterile QA Compliance Officer - Process & CAPA Lead

Inizio Group; Leicester; On-site; GBP 30,000 - GBP 40,000; Full time

Job summary

A leading pharmaceutical company in Leicester is seeking a Quality Officer for a 15-month fixed-term contract. You will act as the primary liaison for QA in sterile manufacturing, ensuring compliance with regulatory standards. Essential requirements include a science-based degree and experience in aseptically manufactured products. This is a full-time role with an immediate start in a highly visible team that impacts product quality and patient safety.

Benefits

Exposure to client audits

Development of QA expertise

Impact on patient safety

Qualifications

• Detail-oriented QA professional with experience in regulated pharmaceutical or medical device environments.
• Experience working with aseptically manufactured pharmaceuticals or medical devices.
• Strong working knowledge of ISO 13485.

Responsibilities

• Managing Quality Systems and GMP compliance within Sterile Manufacturing.
• Investigation and review of Quality Incidents.
• Delivering and coordinating training sessions.

Skills

Attention to detail

Knowledge of ISO 13485

Proficiency in Microsoft Office

Good understanding of EudraLex Volume 4

Education

Science-based degree

Tools

Q-Pulse

TrackWise

Job description

A leading pharmaceutical company in Leicester is seeking a Quality Officer for a 15-month fixed-term contract. You will act as the primary liaison for QA in sterile manufacturing, ensuring compliance with regulatory standards. Essential requirements include a science-based degree and experience in aseptically manufactured products. This is a full-time role with an immediate start in a highly visible team that impacts product quality and patient safety.