Details: Manager  of  Validation   Manages activities of the manufacturing expansion and team validation activities. This includes project scheduling, tracking, and resource allocation in regards to Performance Qualifications for Equipment, Facility, Utility, Cleaning, Process, and Computer Validation studies. Establishes and implements Validation Programs to meet Regulatory requirements and provides QA oversight for the preparation and approval of Validation Master Plans, Project Plans, Protocols, and Final Reports. Interfaces with Manufacturing, Engineering, Utilities, QA, QC, and Regulatory agencies.  n Role/s that report to this position: Validation Scientists   Provides QA oversight for the preparation and approval of Validation Master Plans, Project Plans, Protocols, and Final Reports. Interfaces with Manufacturing, Engineering, Utilities, QA, QC, and Regulatory agencies.   Serves as liaison with other CSL sites to assure harmonization with global validation practices.   Implements and utilizes project management tools necessary to assure proper resource loading and allocation to meet project timelines.   Participates in the interview and selection process for Validation project personnel. Assures that all Validation staff maintain training needs in compliance with existing site standards.   Manages the preparation of study documentation packages, which include data, review, and a summary of each assessment for presentation to management and regulatory agencies, ensuring compliance with cGMPs.   Maintains close contact with Manufacturing, Engineering, and the support labs to assure effective communication on problems and issues related to Validation.   Coordinate the development and execution of Protocols.   Assure adherence to site specific Policies, Plans, and Procedures.

View the original article here