GMP QA Specialist: Quality Systems & Compliance

MedPharm Ltd; Guildford; On-site; GBP 45,000 - 65,000; Full time

Job summary

MedPharm Ltd in the United Kingdom is seeking a QA Specialist to provide Quality Assurance support for IMP manufacturing and QA systems. The role ensures compliance with GMP, GCP and GLP and requires strong review of quality records and documentation.

You will work with Production, QC, Development and external partners to maintain robust data integrity, support CAPAs, and ensure regulatory readiness across site activities.

Qualifications

• Strong working knowledge of GMP, GCP and GLP regulations.
• Experience with Quality Management Systems (QMS) and deviation investigations.
• Experience reviewing batch manufacturing records (BMRs) and quality data.
• Ability to support regulatory inspections and client audits.

Responsibilities

• Raise, review and manage QMS records (deviations, CAPAs, investigations, complaints, risk assessments).
• Review and approve controlled documents within eQMS, ensuring GDP compliance and data integrity.
• Provide QA oversight during manufacturing and laboratory activities.
• Support audits, supplier qualifications and CAPA follow-up.
• Promote data integrity and quality documentation practices.

Skills

GMP/GCP/GLP knowledge

QMS understanding

Documentation review

CAPA management

Audit readiness

Data integrity (ALCOA+)

Education

Bachelor’s or Master’s in a scientific discipline

Tools

MasterControl eQMS

Job description

MedPharm Ltd in the United Kingdom is seeking a QA Specialist to provide Quality Assurance support for IMP manufacturing and QA systems. The role ensures compliance with GMP, GCP and GLP and requires strong review of quality records and documentation.

You will work with Production, QC, Development and external partners to maintain robust data integrity, support CAPAs, and ensure regulatory readiness across site activities.