QA Auditor

Role Overview

Key Responsibilities

• 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 QAU. 


• Plan and organise all activities within the QAU.


• Schedule and perform study, facility and process audits in compliance with SOPs. 


• Communicate the audit outcome to relevant personnel and site management and ensure that audit responses are appropriate. 


• To maintain the CAPA system and follow up CAPA actions.


• Prepare and sign QA statements for inclusion in reports in accordance with SOPs.


• Submit audit reports for archiving in accordance with the applicable SOP.


• To approve 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 GLP, GCP, GMP, or 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.