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.
