Scope of Function: Design and develop electronic document management systems (EDMS) Oversee the implementation of quality systems and Standard Operating Procedures for compliance of appropriate GMP regulations for manufacturing and testing.
Reports to: Associate Vice President, QA, QC & Operation Planning
- Manage/Supervise staff for QA System Compliance Group, including Document Control, Training and QA Facilities management.
- Review, revise, edit and format Standard Operating Procedures, Logbooks, Specifications, Batch Records and other documentation according to written procedures.
- Structure, organize, upload and maintain electronic documents onto the client’s ftp site or other server as needed.
- Maintain storage of Master Files and executed documents in accordance with internal procedures.
- Label generation and reconciliation.
- Spearhead the transition of paper-based system to electronic document management systems (EDMS).
- Enhance Quality Systems Policies to reflect industry best practices. Identify procedural gaps/improvements for transition to commercial testing and manufacturing. Work in tandem with subject matter experts to address gaps.
- Ensure the Quality Systems readiness for regulatory and customer inspections.
- Handle, investigate and close Incident reports, Deviations, Investigations, Change Controls and CAPAs.
- Perform QA review and approval all equipment master records, IQ/OQ/PQ, transfer forms, status change forms, calibration and preventive maintenance records.
- Establish Data Integrity program for all relevant equipment to ensure compliance with 21CFR part11.
- Perform Room/Equipment Compliance and clearance activities as needed.
- Review environmental monitoring data; viable/non-viable particulate; temperature/humidity /air pressure differential Amega data to determine the compliance of the room/equipment. Responsible for working with all relevant parties to address excursions.
- Collate Quality Systems metrics in preparation for quarterly Management Review meetings and Monthly metrics.
- Administer QMS routine meetings such as Deviation and change control.
- Participate as needed in client audits as well as regulatory audits.
- Maintain all establishment licenses.
- Serve as the Officer QA liaison for DEA.
- Submit Annual Updates of DMF to FDA.
Bachelor’s degree in Life Sciences or a related scientific field.
Minimum of seven years’ experience working in a FDA regulated environment.
Proficiency with technical writing and written and verbal communication.