This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:
Ensure that all SOPs and master batch records, paper or electronic, follow cGMP requirements and are in accord with business needs.
Manage the release of commercial lots, review batch records after execution. Participate in the lot disposition decisions and complete lot disposition. Identify issues and support correction process.
Support audits and inspections by ensuring all documents are readily available and organized.
Verify that all products have met all testing requirements and manufacturing specifications prior to releasing the batch records. Identify issues and support correction process.
Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
Provides support for submissions to CBER for release by completing and reviewing the required documentation. Review documentation meets good documentation procedures and calculations are correct.
Manages and/or assists in the disposal of discarded product discovered during inspection process according to procedure.
Collation and organization of batch records for submission to DCO.
Seek continuous improvement opportunities to enhance quality systems
Enters work order completion information into JD Edwards computer applications and enters recorded values in electronic systems.
Manage KPIs for Quality Assurance Release.
Assist in developing and implementing an electronic batch record system.
Good working knowledge of current regulations including FDA, ICH, USP guidance.