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.
Requirements:
- You must have at least 5 years experience in Quality Assurance role in the pharmaceutical industry.
- You must have a minimum of 2 years prior auditing experience conducting (either part of a team or leading) Audits BOTH internally and externally.
- You must have a minimum of 3 years experience writing and reviewing investigations reports including assigning and assessing the effectiveness of CAPA's.
If you are with out these, there is no way round it, the company will not accept an interview request.
The company are truly 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 .
(There is no relocation with this role)