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Validation Specialist III

Company Name:
Talentburst, Inc.
Job Title: Validation Specialist III
Duties:
The Validation Specialist is responsible to:
Work Closely with subject matter experts (SME) to generate validation documents compliant with the site policies and procedures
Perform validation sampling and data analysis of the results
Ensure proper execution/documentation of test results, and compilation of validation packages.
Retrieve and compile data from electronic sources / databases and paper records
Responsible for authoring, reviewing, executing and approving validation documents
Assist in writing Standard Work Instructions and Batch Production Records
Experience:
3 to 9 years. Experience in Cleaning Validation, Process Validation, Equipment Qualification, performance Qualification and/or Filter Validation
Skills:
Proficient in:
MS Office 2010 MS Word, Excel, PowerPoint and Outlook
EDoc with a working knowledge of templates, workflows and approval process
Pharmaceutical Validation, Bio Pharma Validation, Validation execution, Cleaning Validation
Technical writing abilities and time management skills.
Strong root cause analysis skills with cGMP experience.
To be able to establish working relationships with other support and production areas in order to gather all of the necessary information required.
Interact well with a diverse group of individuals.
Self-motivated and willing to be proactive in resolving issues
Demonstrate the ability to successfully interface with QA personnel.
Excellent Verbal and written communication skills. Ability to work in a team environment.
Education:
BS/MS in Engineering, Life Science or Physical Science

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