Description
Our client is a pharmaceutical company and is currently looking for a QA R&D Auditor to help them to improve the quality assurance within their Research and Development Department. The QA GLP Auditor will work at our client for at least 6 months.
Scope of work:
The department:
Quality for R&D is responsible for quality oversight and quality assurance in the GLP, GSP, GCLP, and R&D GMP areas to ensure R&D vaccine development processes are in compliance with regulatory requirements.
Key responsibilities :
* Perform transversal GXP audits within the R&D organization by assessing compliance with QMS standards/GXP requirements and identify issues.
* Carry out independent review of topics identified on a risk based analysis in the relevant part of the organization.
* Make sure remediation activities identified by the audits are in place in order to achieve or maintain the in use status of the quality standards taking into account quality requirements and cost awareness.
* Contribute to creating a mindset oriented towards continuous improvement of quality, ensuring the right balance between the compliance expectations and excessive control.
* Communicate outcomes of the audits related to significant quality or compliance issues to internal stakeholders through appropriate escalation processes.
* Support regulatory inspection preparation activities: pre-audit, facilitation during inspection.
* Remain current with industry trends and changes in the regulatory and GXP standards.
Requirements:
- Minimum a University Degree in Biology, Chemistry, Pharmacy or engineering.
- Experience in (bio)pharmaceutical/vaccines manufacturing and quality operations with awareness of GXP and international standards.
- At least 5-8 years of experience in a pharmaceutical/Biological environment covering various areas: QA, R&D, production, QC and project management roles.
- Strong knowledge of regulatory and GXP regulations (European, US, Japanese, WH0 ...).
- Qualified/Certified in audit is a plus.