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Wilmington PharmaTech

Quality Assurance - Associate Director/Director

Wilmington PharmaTech, Newark, Delaware, United States, 19711


Quality Assurance - Associate Director/DirectorKey Responsibilities/Qualifications:

Wilmington PharmaTech (WPT) is looking for a Quality Assurance Specialist with GMP experience in the API / pharmaceutical industry for our brand new API pilot plant. The role includes leading and overseeing Document Review & Batch Release, QA Product Management, Customer Complaints, CAPAs, Document Change Control, Management Review/KPI & Compliance Initiatives in an FDA regulated environment.

Ideal candidates should have a strong understanding of Good Manufacturing Practices and API / pharmaceutical manufacturing, new product development projects, project management experience, demonstrated proficiency in acting as a customer-facing quality representative, proven managerial experience with demonstrated success in communicating, leading, and motivating others to succeed, experience building teams and developing succession plans is highly desirable, and must be a strategic driver of change with excellent writing skills.

A degree in chemistry with a minimum of 3 years of experience is desired within either the API or pharmaceutical manufacturing environment; food or medical device industry experience may be considered. Strong cGMP knowledge & strong problem-solving ability required.

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