Sr. Manager Quality Assurance
Englewood Lab, Inc
Totowa, new jersey
- Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups.
- Trains and supervises document review personnel; batch release personnel, Maintains accurate record of approved, quarantined, rejected products.
- Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).
- Review and release final product and maintain authorized person (AP) status; also reviews release and compliance of bulk and intermediates where applicable.
- Conduct audits and inspections; also prepare draft responses to audits and inspections
- Oversee/coordinate drug stability program.
- Oversee process validation lifecycle program.
- Oversee document control program.
- Maintains working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods.
- Ensures that review of...