Job Overview:
We are seeking a highly skilled Associate Director of Validation (10+ years experience) to join our team as a consultant for a 6-9 month on-site Contract in Rockville, MD.
1. Review and enhance Validation Master Plan to include comprehensive facility and equipment qualification lifecycle.
2. Gap Assessment of Validation Plan for both Facilities and Computer Systems
3. Review and create recommendations regarding completed commissioning of production suites.
4. Review and create recommendations for commissioning work on new facility buildout to include material warehouse.
5. Oversight of CSV activities for Document Control and Training Systems (should be able to provide high level guidance)
6. Train new hires in QE/Validation space
7. Provide guidance on maximizing product capacity and use of GMP suites.
8. Review and enhance CSV program.
1. SOP development
2. Develop and manage inventory of computer systems software.
3. Assessment of all equipment- identify gaps for early phase to pivotal transition and related requirements for data integrity.
9. Review current risk scenarios and advise on additional risks.
10. Author SOPs and perform validation as needed.
Job Type: Contract
Pay: $80.00 - $120.00 per hour
Experience:
- Management: 5 years (Required)
Ability to Commute:
Work Location: In person