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.