Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards. Will provide GMP, GLP and ISO 13485 compliance support as necessary.
- Audit reports and raw data for compliance with protocols, SOPs and regulations, including design verification, stability, aging, sterilization, and validation.
- Review manufacturing, QC, release records, and documentation for medical device and drug substance/drug product.
- Oversee change control program, including review of change documentation, tracking activities, and verification of effective implementation.
- Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
- Identify compliance weaknesses and ensure the implementation of workable solutions.
- Write/revise/review SOPs/INSs, prepare flow charts and other quality documentation, including investigation reports, audit reports, quality metric trend reports, etc.
- Perform other related duties as required.
Sthree US is acting as an Employment Business in relation to this vacancy.