The QS Systems Administrator – Annual Product Review System Administrator and Internal, Customer, and Regulatory Audit System Administrator fully understands GxP principles as regulated and guided by domestic and international regulatory requirements.
Coordinates and manages all aspects of the Annual Product Review System at predefined time intervals to summarize quality systems for verification against actual practices and conformance to quality standards.
Coordinates and manages all aspects for the Site Internal Audit Program, Customer and Regulatory Audits/Inspections.
The QS Systems Administrator reports to the Quality Systems Manager.
Primary responsibilities of this role include the following:
Annual Product Review System Administrator:
- Manage all aspects of the APR program
- Monitor program performance and compliance
- Work with internal resources to define requirements for analyzing and reporting data
- Provide summary and statistical analysis of all data for all APRs.
- Work with customer contacts to meet all APR requirements
- Track product/site performance and focus on continuous improvement.
Site Internal / Customer /Regulatory Audit/Inspection Administrator:
- Maintain the internal Audit schedule
- Manage all audit events including performing Internal Audits
- Monitor all audit related findings and actions
- Provide management status reports
- Provide guidance/training to involved personnel (as appropriate)
- Coordinate the planning, hosting and follow-up activities to all customer and regulatory audits.
On request provide support for other Quality Systems, i.e. SOP System, CAPA, etc.
- BS degree in Chemistry, Life Science, Engineering or combination of training, education, and experience that is equivalent.
- A minimum of 5 years pharmaceutical industry experience.
- A minimum of 2 years’ experience with statistical analysis.
- Previous work experience should include exposure to a broad range of Pharmaceutical Quality Assurance activities such as production record review, Quality Control, GMP Auditing, standards development, material specifications/testing, etc.
GMP DECISION-MAKING AUTHORITY
Has authority to manage and report on all aspects of the APR and Audit systems as defined above.
Approval authority for GMP Documentation will be designated by Quality Leadership as needed.