To review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics.
- Review manufacturing batch records, testing results and deviation reports
- Interact with other departments to address review observations
- Release drug product, drug product components and container-closures
- Interact with customers on batch record reviews and batch releases
- Attend department meetings on batch record review and releases
- Maintain and report quality metrics on batch record review and releases
- Review and write standard operating procedures
- Review quality system documents (change controls, validation, complaints)
- Review master batch records and maintain records
- Process, investigate and follow-up on product complaints
- Perform other tasks as requested by management.
- Bachelor’s Degree (BA or BS), preferably in a Natural Science, is required
- A minimum of 3 years of relevant experience in the pharmaceutical industry is required.