Job Description

Job Purpose

We are seeking a Quality Assurance Auditor to ensure compliance with regulatory standards and company procedures. In this role, you will plan and conduct audits of facilities and processes, monitor corrective and preventative actions, and maintain quality systems. You will also review and update SOPs, assess suppliers, and provide training and guidance on quality matters. By supporting inspections and preparing QA documentation, you will help safeguard the integrity of our operations and drive continuous improvement across the organisation.

Main Areas of Responsibility

Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans. Participating in the maintenance of the quality system. Forecast, monitor and control the work volume within Quality Assurance Unit (QAU). Plan and organise all activities within the QAU. Schedule and perform study, facility and process audits in compliance with Standard Operating Procedures (SOPs). Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate. To maintain the Corrective Action/Preventative Action (CAPA) system and follow up CAPA actions. Prepare and sign Quality Assurance (QA) statements for inclusion in reports in accordance with SOPs. Submit audit reports for archiving in accordance with the applicable SOP. To approve Good Manufacturing Practice (GMP) documentation where applicable. To participate in computerized system validation team where applicable. Review Standard Operating Procedures for consistency and compliance and maintaining QA SOPs. Manage and conduct assessment of key company suppliers as requested by management to ensure compliance with regulatory guidelines. Provide guidance, training and consultation in quality-related issues. Support QA Manager in management and hosting of sponsor and monitoring authority inspections. Observe appropriate regulatory guidelines, SOPs, policies and study documentation. Working in accordance with standard operating procedures (SOPs) by authoring, reviewing, and maintaining SOPs, guidance documents, and policies, as well as providing training and support to staff.

Qualifications & Experience

Required:

Minimum 2 years' experience in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), or International Organisation for Standardization (ISO) environments. Degree in a relevant natural science. Understanding of national laws and relevant regulations and guidelines and SOPs and site related functions. Proficient in written and spoken English. Strong attention to detail, communication, problem-solving, and organisational skills. Able to work independently and collaborate effectively in a team. Proactive and decisive with a scientific background (desirable). Willing to travel as needed.

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.

Synexa Life Sciences is committed to achieving transformation and will take it's EE plan and targets into consideration during the selection process.