Occupation:Clinical Quality Assurance |
Location:Clarkesville, GA |
Education Level:Bachelor |
Will Relocate:YES |
Description
QA Manufacturing Compliance Lead Lead QA Validation Remediation - Comprehensive Product and Process gap assessments of HVAC, Utility Maintenance programs, product Scale-up through commercial validation, packaging and manufacturing process failures, and customer complaints for Prescription, OTC & DEA products. Conduct review of CMO validation change control and QC OOS/OOT reports and write annual Product Review for all products form three different CMOs
Accomplishments
Highlights:
Keywords
- Training
- Project Management
- Distribution
- Management
- Risk Management
- CFR Part 11
- Design Specification
- pharmaceutical
- protocol
- Leadership
- Staff development
- cleaning validation
- process validation
- computerized systems validation
- Program Management
- QC testing
- Chemist
- CAPA
- NCR
- Customer Complaints
- Supplier Quality
- commissioning
- equipment qualification
- equipment purchase
- Change control
- Auditing
- Medical Devices class I, II and III
- Pharmaceutical development DOE
- Pharmaceutical Clinical Scale-up
- Mfg./Pkg. Management
- ISO13485
- Technical Reporting
- FDA site QA contact
