Description
Description:Candidates must posses 7 or more years experience supporting validation programs and possess a BS degree, preferable in the Science or Engineering fields (or equivalent experience). Responsible for creating and implementing Abbott Vascular's validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
1. Represents the company during internal and external audits of validation projects and documentation.; 2. Writes validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.; 3. Manages the execution of validation protocols, as protocol directors, in assurance of timely and cost efficient completion through specialized experience and training.; 4. Evaluates validation results of validation protocol executions employing specialized experience and training.; 5. Consults with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience.; 6. Manages Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.; 7. Performs validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.; 8. Tracks and reports validation progress of corporate validation projects through departmental project tracking tools.
Manager is looking for candidates who are strong with quality related validations (process validation, test method validations). Not as strong in Facility/Equipment Validation.
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