Essential Job Function:
Responsible for interacting with customers on quality issues. Responsible for the receipt of all Notices of Investigations and logging them into the Investigations spreadsheet.
Responsible for the receipt of independent CAPAs and logging them into the CAPA spreadsheet.
Responsible for reviewing investigation reports for accuracy, compliance and completion.
Responsible for performing internal and external audits and completing the pertinent audit agenda and reports.
General Information: Experience in the pharmaceutical industry.
Bachelor’s Degree in Science field desired.
JOB RESPONSIBILITIES INCLUDE BUT NOT LIMITED TO:
- Investigate deviations and initiate the appropriate corrective and/or preventive actions to prevent re-occurrence of the incident.
- Perform root cause analysis.
- Perform product impact assessment of deviations.
- Provide QA support during the investigation process.
- Perform tracking and trending of deviations and CAPAs.
- Prepare Deviation and CAPA metrics on a monthly basis.
- Provide support during FDA inspections.
- Responsible for the receipt all Notices of Investigations and logging them into the Investigations spreadsheet.
- Responsible for the receipt of independent CAPAs and logging them into the CAPA spreadsheet.
- Communicate all deviations to the appropriate customer.
- Receive all customer complaints, log them into the spreadsheet and forward them to the appropriate department for investigation.
- Identify quality/compliance deficiencies and report them to Compliance Management.
- Initiate change controls related to CAPAs or process improvements.
- Perform internal and external audits and complete pertinent agenda and reports.
- Conduct pre-inspection audits internally to assess areas of regulatory risk in preparation for inspections/audits by regulatory agencies and/or clients.
- Identify, report and investigate trends associated with deviations.
- Write trend investigations as required.
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