Annual Product Review Specialist

Sunrise, FL

Posted: 05/08/2019 Job Number: JN -052019-10752
Annual Product Review Specialist :

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Annual Product Review Specialist
  • Location: Sunrise, FL
  • Industry: Pharmaceutical
  • Shift: Monday Friday; 8:00 am 5:00 pm
  • Salary: Up to $28.00 hour paid weekly with benefits options
  • Employment Type: Contract 6 months with possible extension or conversion
Environment: This client is a worldwide leading generic pharmaceutical company and one of the top 15 companies in the industry. With over 45,000 employees in 60 countries worldwide, they are proud to say that our employees are the reason for our success . They believe in empowering employees, presenting them with new challenges and letting them grow and develop professionally. Isn t this the type of company you want to work for?
Job Scope:
  • Provide sub reports for APR, annual product review
  • Process change controls and update as needed
  • Prepare APR report to show product performance, validation status and determine compliance
  • Prepare monthly and quarterly APR metrics
  • Create quarterly APR schedule
  • Attend product scorecard meeting and prepare meeting minutes
  • Participates in Audits
  • Responsible for statistical data of in-process, finished products and stability
  • Monthly monitoring of product scorecards
  • Entering APR configuration in LIMS

Requirements:
  • Bachelor s Degree in Science, Engineering or related field
  • 5-7 related experience preferably in a quality assurance environment
  • Quality Assurance/Regulatory Compliance experience with Annual Product Review
  • Knowledge of cGMPs, SOPs, and FDA, and other regulatory compliance regulations and standards
EOE/ADA

Annual Product Review, APR, Quality Assurance, Regulatory, Compliance, cGMP, GMP, FDA, Pharmaceutical
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