Working 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
Provide Fermentation Expertise
Candidates need to be able to work a flexible schedule with weekend work may be required. Basic technical writing and communication skills are desirable.
Skills, MS Office 2010, E Doc, Pharmaceutical Validation, Bio Pharma Validation, Validation execution,
Technical writing abilities and good time management. Strong root cause analysis skills with cGMP experience. Excellent Verbal and written communication skills.
Ability to work in a team environment. 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.
Pharmaceutical Validation, Bio Pharma Validation, Validation execution
Operation of Fermentation processes
Tunnell Consulting, Inc.