Description
Our client is a global Pharma/Biotech company with facilities headquartered in San Diego. We are seeking a motivated candidate to fill the role of Validation Director. Here is information on the scope of work:2.3 Evaluations and execution work will consist of validation activities to be assigned during the contract period. Execution work may consist of the following:
2.3.1 Document Review
A. Review current client Philosophy and approach to cleaning validation (validation master plan)
B. Review current cleaning limits reports (3)
C. Review current Standard Operating Procedures (SOPs) relevant to cleaning limits and cleaning validation
2.3.2 Generation
A. Following review, development a high level outline of proposed plan
i. What document revisions are necessary to update current practice and philosophy to meet industry expectations
ii. What documents (or sections) should be combined to enhance document review and presentation
iii. What clarifications should be made to make the Limits Report more presentable
B. Receive approval of plan
C. Execute Plan
D. Final reports and assembly of final report packages
2.3.3 Deliverables include:
A. Comprehensive Cleaning Limits Report
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