QA Manager (Documentation)
JOB TITLE: QA Manager
DEPARTMENT: Quality Assurance
REPORTING TO: Director, QA
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIY
Responsible for the GMP Document Control System that includes:
- Quality Assurance documentation system: life-cycle of documents (creation, distribution, revision, review cycle, implementation) including periodic review cycles.
- Document Change Control system
- Site wide logbook lifecycle process
- Site’s Retention Schedule and Archival Process to ensure that documents are appropriately retained, retrievable and destroyed
- Manage the process for the filing and retrieval of completed Training Records.
- Supervision of a team of Documentation Specialists. Responsible to allocate workload, provide objective setting and performance review discussions.
- BA or BS degree in a scientific discipline.
- At least 10 years of experience in cGMPs at an operational level supporting manufacturing or testing in a pharmaceutical environment with an additional minimum of 5 years of experience in a direct QA Documentation function working within / responsible for Quality Systems
- Knowledge of GMP, USP, EP, and CFR requirements and regulations
- At least 3 years of experience directly supervising direct reports