Job Offer QA2021_02
Summary of Key Responsibilities :
- Support the continued development and maintenance of the Quality Assurance document management systems
- Manage documents through approval, issuance and archiving processes
- Provide user support and training for document management systems
- Track and close-out deviation and change control documentation
- Conduct quality data reviews of GXP documents
- Coordinate and conduct GXP Training and Maintain GXP training files
- Conducts internal system/process audits to ensure compliance with company policies/procedures, if applicable
- Coordinate external GXP audits and track audits through their lifecycle to closure
- Develop, recommend and monitor corrective and preventive actions to ensure that quality issues are resolved and prevented in future through proactive and coordinated employee training and process innovation.
- Research changes and updates to ICH, GXP regulations
- Collaborate with cross-functional teams to facilitate the document review process
- Author corporate Quality Systems policies and SOPs and support the continued development of the Quality Systems
- Perform other QA functions as necessary to maintain quality oversight of ongoing activities and quality initiatives.
- At least Bachelor’s degree in a scientific discipline or biotechnology field
- GCP certified
- Strong pharmaceutical industry experience in Quality Assurance and document management.
- Strong understanding of cGCPs, FDA, EMA and ICH regulatory standards/guidance documents. GMP and GLP experience is a plus. (Junior or Senior level according to experience in all the previous noted guidelines)
For any application, please contact firstname.lastname@example.org