One of your main tasks will be to investigate complaints, deviations, out-of-specifications (OOS) and non-conformities, draft a report on these and propose corrective and preventive actions (CAPA).
You will take on a part of the batch release activities of the medicines and other medical products produced on site. Additionally, you will monitor compliance to the internal Standard Operating Procedures (SOPs) and GMP (flows and zoning included) in production and the laboratory.
More specific:
- Investigation and drafting of report for deviations; OOS; complaints and non-conformitiesMonitor compliance on internal standard operating procedures (SOP’s) and GMP in production and laboratory area
- Final batch release - including review of batch records (1-2h per day)
- GMP/GDP/Pharmacovigilance training of QC and production operators; warehouse workers and drivers.
- Writing of the yearly PQR (Product Quality Review)
- Review of QC and GMP procedures
- Involvement in GMP validation and qualification activities (equipment and processes in production and laboratory area) and other GMP projects
- Management of CAPA’s related to GMP activities
- Management of change controls related to GMP activities
- Support during (preparation of) audits on site
- Perform internal audits at other sites and suppliers