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Form of workJob Description
Summary: Responsible for managing the Quality Systems Program, including deviations, corrective and preventative actions (CAPA), change control, supplier qualification, KPI, and environmental programs.
Requirements:
- Bachelor’s degree in a scientific discipline.
- Minimum of five (5) years of experience with FDA and cGMP requirements in a pharmaceutical environment.
- Minimum of five (5) years of experience with Quality Assurance/Quality Control practices in a pharmaceutical environment.
- Advanced understanding of manufacturing in a cGMP environment, documentation, and data integrity requirements.
Responsibilities:
- Manage the Quality Systems Program, including deviations, CAPA, change control, supplier qualification, KPI, and environmental programs.
- Write, review, and/or approve deviations, complaints, Quality System Standard Operating Procedures, change controls, and specifications.
- Write, review, and/or approve manufacturing instructions and/or batch records.
- Oversee product release activities, including batch record review, product disposition, returns, salvages, recalls, product improvement, and product annual review.
- Conduct/assist in investigations of deviations and CAPAs, Out of Specifications (OOS’s) for Release/Stability, and Out of Trends (OOT’s).
- Provide oversight of the training program documentation and offer training as required.
- Write, review, and/or approve OOS, including stability OOS.
Pay Details: $90,000.00 to $95,000.00 PER YEAR
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.
Specializes in custom automation projects, they are a major player in the world of controls and robotic solutions around the world. My client will expand anyone resume and build them to be a top performing controls engineer.
