Senior Quality Assurance Auditor

Job Purpose

The Senior Quality Assurance Auditor ensures compliance with regulatory requirements, SOPs, and study plans. They plan, organize, and conduct audits of studies, facilities, processes, and suppliers to maintain quality standards. The role manages CAPA systems, reviews and approves GMP documentation, and supports computerized system validation where applicable. By preparing QA statements, maintaining SOPs, and communicating audit outcomes, the auditor strengthens the site’s quality systems. They also provide training, guidance, and support during inspections, fostering continuous improvement across the organization.

Main Areas of Responsibility

• Follow and where applicable implement appropriate laws, regulatory guidelines, SOPs, Study Plans.
• Support QA Manager in implementing the quality assurance program and assist in continuous improvement of the site's quality systems.
• 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’ auditing experience in GLP, GCP, GMP, or ISO environments.
• Degree in a relevant natural science.
• Strong 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.