Address
Form of work Consultant's day to day responsibilities:
Required skills:
- Initiating investigations resulting from product deviations and non-conformance issues.
- Assisting with the development of CAPA's
- Visual inspection and observation of production process and staff in the GMP manufacturing suites. Participation in walk throughs.
- Review and approve deviations.
- Compile and review raw data and sample test results, including Final Reports and CoA's
- Review and approve executed batch records.
- Reviewing environmental monitoring trend reports and generating environmental summaries
Required skills:
- 2+ years-experience in a QA, QC or Manufacturing role
- Associate or Bachelor's degree
- Previous experience working in a life science, pharmaceutical or medical products GMP environment.
- Prior experience with batch record review.
- Previous experience reviewing and approving deviations or investigations.
- Previous experience with LIMS, QMS or other database for documentation and review of SOP's: paperless environment
