Position will complete Annual Product Reviews within the QA Department. Responsibilities include compiling product data for review period including batches manufactured, manufacturing and laboratory investigation, product quality complaints, stability data, change controls, validation activities etc. The individual will also be responsible for reviewing, and generating the final report summarizing product trends and product performance, in addition to supporting QA’s involvement in the Change Control Process.
• Ensures adherence to established SOPs for conducting and generating Annual Product Review Reports.
• Reviews, summarizes and generates a management report of product data.
• Experienced at preparing executive summaries for individual products.
• Functions as a liaison between several internal departments.
• Produces a final report for review and approval in a timely manner identifying any negative trends indicating. concerns for product quality and initiating corrective actions upon management approval.
• Participates, leads and/or coordinates meetings related to the APR Process.
• Assist in QA Change Control Process.
• Assist during FDA inspections pertaining to training.
• Assist in other QA functions as deemed necessary.
• Write, Review, and Implement SOP’s to ensure compliance with Regulation and High Tech Policies.
Qualifications
Subscribe to job alerts and upload your resume!
*By registering with our site, you agree to our
Terms and Privacy Policy.