Description
JOB RESPONSIBILITIES INCLUDE:- 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.
The company are truely great group of people and are located in a lovely area of northern New Jersey. If you feel you could bring value to the company as Compliance Specialist the please get in contact by sending your cv or calling .