QA Officer — 24/7 GMP Compliance (Site)

Kedrion Biopharma GmbH; Elstree; On-site; GBP 40,000 - 50,000; Full time

Job summary

A biopharmaceutical company in Elstree is seeking a Quality Assurance Officer to manage compliance within a regulated environment. The role involves acting as the primary QA contact, managing quality incidents, and conducting audits. Strong knowledge of Quality Management Systems and experience in sterile environments are necessary. This is a 24/7 position, providing a dynamic opportunity for professional growth within an international company committed to patient safety and product quality.

Benefits

Pension

Life Insurance

On‑site parking

Subsidised canteen

Employee discounts and cash back

Family friendly policies

Employee recognition programme

Qualifications

• Experience working in a regulated quality environment.
• Understanding of GMP and GxP requirements.
• Competent with root cause analysis and error risk reduction tools.

Responsibilities

• Act as the primary Quality Assurance contact across site during the shift.
• Manage quality incidents and deviations using TrackWise.
• Conduct QA walk rounds, audits and inspections across manufacturing.

Skills

Experience in sterile aseptic filling and packaging environments

Familiarity with TrackWise and LIMS systems

Knowledge of UK/EU and US regulatory requirements

Experience with continuous improvement tools and methodologies

Excellent attention to detail

Strong knowledge of Quality Management Systems

Confident communicator

Ability to work cross-functionally

Education

Degree-level qualification in a scientific discipline

Tools

TrackWise

Job description

A biopharmaceutical company in Elstree is seeking a Quality Assurance Officer to manage compliance within a regulated environment. The role involves acting as the primary QA contact, managing quality incidents, and conducting audits. Strong knowledge of Quality Management Systems and experience in sterile environments are necessary. This is a 24/7 position, providing a dynamic opportunity for professional growth within an international company committed to patient safety and product quality.