QA Specialist: GMP/GCP/GLP Compliance Expert

MedPharm; England; On-site; GBP 40,000 - 60,000; Full time

Job summary

MedPharm is seeking a QA Specialist to provide Quality Assurance support for IMP manufacturing and related QA systems. The role collaborates with Production, QC, and Development to ensure GMP/GCP/GLP compliance, review quality documentation, and maintain data integrity across quality records and investigations.

Responsibilities include QMS management, document control, batch release support, supplier qualification, and audits.

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline.
• Minimum 2 years’ experience in a GMP-regulated pharmaceutical or biotechnology environment, preferably supporting IMP manufacturing or clinical trial supply.
• Experience working within a QMS including deviations, CAPAs, change controls, investigations and audit responses.
• Experience reviewing BMRs, manufacturing documentation and quality data to support batch release and QP certification.
• Experience supporting regulatory inspections, client audits and internal audits in GMP environments.

Responsibilities

• Review and manage QMS records including deviations, CAPAs, investigations, and quality risk assessments.
• Review and approve controlled documents (SOPs, forms, protocols, reports) in the eQMS, ensuring GDP and ALCOA+ data integrity.
• Provide QA oversight during manufacturing and laboratory activities and support investigation into manufacturing deviations.
• Support supplier qualification activities including supplier assessments, audits and technical agreements, and ongoing supplier performance monitoring.
• Ensure quality documentation and electronic records comply with data integrity requirements and regulatory expectations.
• Participate in internal self-inspections, supplier audits and preparation for regulatory inspections.
• Deliver GMP and Quality training where required and assist with QA training records.

Skills

GMP/GCP/GLP

QMS experience

Deviation investigations

Change control

Audit readiness

BMR review

Documentation control

Data integrity

Cross-functional guidance

Education

Bachelor's or Master’s in science

Tools

MasterControl

eQMS

Job description

MedPharm is seeking a QA Specialist to provide Quality Assurance support for IMP manufacturing and related QA systems. The role collaborates with Production, QC, and Development to ensure GMP/GCP/GLP compliance, review quality documentation, and maintain data integrity across quality records and investigations.

Responsibilities include QMS management, document control, batch release support, supplier qualification, and audits.