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The Principle Scientist, Quality Validation will provide quality oversight to the site facility and equipment qualification and process/product validation program.
This individual will manage the site qualification and validation programs for facility, equipment and manufacturing and packaging processes utilizing Quality Risk Management tools and develop and maintain the Site Master Plan.
This individual will provide quality support and oversight to the criticality assessment process.
The Principle Scientist, Quality Validation will also provide quality support and approval of protocols and reports.
This individual will assess impact of deviations from approved protocols utilizing Quality Risk Management Tools, support the Quality System Management Review Program and support the introduction of New Products to assure compliance to all standards and robust product supply.
This individual will communicate to management in accordance with the management event and notification quality system procedure.
The Principle Scientist, Quality Validation will interact with Regulatory Health Authority representatives during inspections and support responses to Regulatory Health Authorities.
A Bachelors degree is required. A focused degree is preferred in sciences or engineering. An advanced degree is preferred. A minimum of 7 years of experience in the pharmaceutical industry or other highly regulated industry is required. Thorough knowledge of cGMPs and regulatory requirements/guidance are required. Experience interacting with Regulatory Health Authorities is preferred. Plant experience is preferred. Experience mentoring/managing others is preferred. Experience with facility and equipment qualification OR process and packaging validation OR developing a requalification program for a facility is required.
Strong negotiations and influencing skills are required. Strong interdependent partnering and verbal and written communication skills are also required.
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