The Position
is a drug product & finished goods manufacturing organization responsible for the reliable delivery of commercial portfolio & pipeline products. The Operations organization at is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.
The Opportunity:
In this exciting role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards to provide quality oversight for the site qualification/validation program. You will perform quality oversight of qualification and validation activities associated with equipment, facility and utility systems, GMP computerized systems, drug product manufacturing processes, cleaning processes, sterilization processes, and analytical methods. This is inclusive of, and primarily in support of, technology transfer and process validation.
You will provide guidance to internal customers on best practices for executing consistent, reproducible, and compliant qualification and validation activities.
You will provide assessment and approval for changes that impact the validated state and/or require qualification/validation.
You will review and approve a variety of documents to support qualification and validation activities, ensuring compliance with internal quality system requirements.
You will provide input and quality oversight to qualification/validation exceptions/deviations.
You will work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.
You will exercise judgment based on the analysis of multiple sources of information and interactions with peers and cross-functional squads.
Who you are:
You hold a Bachelors degree with 8 years industry experience or Masters degree with 5 plus years.
You have biopharmaceutical or pharmaceutical industry experience in technical validation or quality validation, and strong technical knowledge of qualification and validation principles.
You have an ability to interpret and relate quality standards for implementation and review.
You have the ability to make sound decisions about quality and technical subjects.
You exhibit sound knowledge of cGMPs or equivalent regulations.
You have flexibility in problem solving and work hours to meet business objectives.
You are able to quickly and consistently establish rapport and collaborate effectively with team members and partners.
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