Job Title: Quality Auditor

Job Overview

An exciting opportunity is available for an experienced Quality Assurance (QA) professional to join a Global Development Quality team as a Quality Auditor. This role offers exposure to a wide range of investigational medicinal products, from small molecules to complex immunotherapy treatments, contributing to the delivery of life-saving and life-changing medicines.

As a Quality Auditor, you will be responsible for the final review of clinical batch records to ensure compliance with Good Manufacturing Practice (GMP) and alignment with regulatory filings. You will compile and approve data packs for Qualified Person (QP) release, collaborating with global functions and clinical manufacturing sites worldwide. The role requires strong communication skills, issue resolution capabilities, attention to detail, and the ability to work independently.

Key Responsibilities

• Conduct routine audits of data, procedures, equipment, systems (including computer systems), and facilities to ensure compliance with SOPs, GMP, and global regulations.
• Review and approve production and analytical documentation for the release of API, Safety Assessment, or clinical supply lots (bulk and packaged).
• Communicate and resolve audit findings with relevant departments.
• Perform audits or inspections under supervision or as part of a team to assess regulatory and internal compliance.
• Issue reports summarizing deficiencies and support remedial actions.
• Notify management of inspection results and follow up on corrective measures.

Required Experience & Skills

• Experience in the pharmaceutical or chemical industry, or within a drug-regulatory agency.
• Working knowledge of current GMP regulations.
• Strong oral and written communication skills.
• Effective interpersonal skills.

Qualifications

• Prior experience in a QA or similar role within a GMP environment is preferred.
• Applications are also welcome from recent science graduates (Bachelor’s degree minimum) with a proactive attitude and eagerness to learn.