Onsite GMP/GLP QA Specialist & QMS Lead

MedPharm Ltd; Guildford; On-site; GBP 35,000 - GBP 45,000; Full time

Job summary

A leading pharmaceutical company in Guildford is seeking a QA Specialist to ensure compliance with GLP, GMP, and MHRA standards. Responsibilities include overseeing daily QA activities for IMP manufacturing, supporting training in GxP-compliant procedures, and conducting internal audits. Candidates should have a Bachelor's degree and a minimum of 3 years in a GMP-regulated QA environment. This role demands attention to detail and proficiency in document management systems, with occasional travel required for audits and training.

Qualifications

• Minimum 3 years of experience in a GMP-regulated QA environment.
• Experience in GMP manufacturing, batch release, and QMS management is essential.
• In-depth knowledge of GCP and clinical trial regulations.

Responsibilities

• Oversee day-to-day QA activities associated with IMP manufacturing.
• Provide quality oversight for batch record review and document approval.
• Lead internal audits and support regulatory audits for compliance.
• Maintain and improve the Quality Management System.

Skills

Knowledge of GMP

Quality oversight

Attention to detail

Excellent communication skills

Organizational skills

Proficient in Microsoft Office

Education

Bachelor's degree in scientific or related discipline

Tools

Electronic QMS

Document management systems

Job description

A leading pharmaceutical company in Guildford is seeking a QA Specialist to ensure compliance with GLP, GMP, and MHRA standards. Responsibilities include overseeing daily QA activities for IMP manufacturing, supporting training in GxP-compliant procedures, and conducting internal audits. Candidates should have a Bachelor's degree and a minimum of 3 years in a GMP-regulated QA environment. This role demands attention to detail and proficiency in document management systems, with occasional travel required for audits and training.