Quality & Regulatory Documentation Specialist

Henry Schein, Inc.; Gillingham; On-site; GBP 30,000 - 42,000; Full time

Job summary

Henry Schein UK Holdings Ltd is seeking a quality/regulatory document controller for the UK & Ireland. Based at the Gillingham office, you will manage QMS/EMS document control, support SOPs, records, and audit schedules while driving continuous improvement.

You will have 2–3 years of quality systems experience in pharma/medical devices, with GDP and ISO awareness, and strong English communication to collaborate with internal teams and regulatory authorities.

Qualifications

• 2–3 years’ experience in a Quality and/or Regulatory role.
• Regulatory Affairs and Quality System and/or Environmental Management experience.
• Knowledgeable in Good Distribution Practice (GDP).
• Awareness of ISO 9001 and/or ISO 14001 quality/environmental management systems.
• Fluent in written and spoken English.

Responsibilities

• Act as the document controller for UK & IE locations under the QMS.
• Publish and revise QMS/EMS SOPs and WI with proper approvals.
• Maintain QMS/EMS schedules, audit schedules, and records.
• Coordinate risk assessments, CAPAs, deviations and environmental programs.
• Support continual improvement initiatives and Management Review data.
• Assist in filing systems and training procedure updates.
• Help develop QARA & EMS intranet documentation access.

Skills

Quality systems

Regulatory affairs

GDP knowledge

ISO 9001/ISO 14001 awareness

Education

Bachelor's in Regulatory Affairs / Life Sciences

Tools

Microsoft Office

Excel

Job description

Henry Schein UK Holdings Ltd is seeking a quality/regulatory document controller for the UK & Ireland. Based at the Gillingham office, you will manage QMS/EMS document control, support SOPs, records, and audit schedules while driving continuous improvement.

You will have 2–3 years of quality systems experience in pharma/medical devices, with GDP and ISO awareness, and strong English communication to collaborate with internal teams and regulatory authorities.