Duties:
Quality Systems Team (QST) is responsible for the design, implementation, and continuous improvement of GxP Quality Systems globally. The QST is a service-oriented function dedicated to enabling effective, efficient, fit-for-purpose Quality Systems to support GMP, GDP, GCP, GVP Operations and Quality functions. This individual will be responsible for supporting critical sub-systems of Quality Management System including GxP Vendor Quality Oversight Program, Internal Audits, and the GxP Training Program. Candidate will take on additional responsibilities, projects or administrative tasks, as workload allows, as required.
Skills:
Vendor Quality Oversight & Internal Audits Support identification, onboarding and coordination of contract auditors Facilitate creation, review and approval of documentation of the vendor audit lifecycle (i.e. new vendor request forms, audit agendas, audit reports, vendor responses, audit closure) Quality Agreement facilitation Coordinate and support internal audits Training Management Administration New Hire Onboarding in GxP Initiation and processing of new hires in Learn Review and Upload Curriculum Vitae(s) (CVs) in Learn Review and Upload Job Description(s) (JDs) in Learn Support other training administrator duties, as needed Support GXP inspection readiness as required
Keywords:
Education: Bachelor's degree required 7+ years of experience in Quality Assurance or Quality Operations. Broad knowledge of risk-based quality systems approaches including Vendor management, Training, and other elements of a QMS Experience in Vendor Management including qualification, oversight, metrics across GMP/GDP, GCP, GVP, GLP Knowledge of GxPs (FDA, EMA and ICH) Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner Initiative and self-motivated to drive process/programs forward with focus on innovation and stakeholder support Attention to detail as well as a crisp, clear and concise style in written and oral communications Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment Experience supporting inspection-readiness activities resulting in successful agency (FDA, EMA) inspections.
Schedule:
Start Date: 08/15/2022
Estimated End Date: 02/17/2023
Hours Per Week: 40.00
Hours Per Day: 8.00
Start date: ASAP
End date: 6 months from start
* Possible conversion or extension based on performance and business needs
Must Haves:
- Pharm/Bio quality role
- Auditing background
-Electronic systems
-Administrative/training background
-Vendor management
Nice to have exp in:
- Metrics
-KPIs
-Compliance Wire (system)
-Veeva