Quality Assurance Analyst

Piramal Enterprises
Full time Full day
New Berlinville, PA

QA Analyst




Supports activities of the QA group relative to the Annual Review Process and Quality Complaint Investigation activities to maintain compliance with cGMPs.




Essential Duties & Responsibilities


  • Works under Minimal supervision

  • Completes Annual Product Reviews within the assigned due date to meet site quality metrics. Reviews are to be complete, accurate, and set up in the standard format.

  • Opens the Parent Record and Child Record for Customer Complaints. Completes Customer Complaint Investigations within the assigned due date to meet site quality metrics. Makes CAPA recommendations as necessary. Forwards the completed/approved complaint to the product ANDA holder
  • Updates Internal Control Limits and Action Limits based on Annual Product Review information. Updates the ICL spreadsheet as needed

  • Shares responsibility for maintaining product reserve samples and Batch Record entry into TrackWise
  • Assists in preparing and updating SOPs and Work Instructions
  • Completes the monthly compliance metrics. Completes monthly APR and Complaint presentation slides for Quality Council Meeting.

  • Performs other duties as assigned or required by business needs.



Qualifications



Qualifications

Education: 4-year degree in biology, chemistry, biochemistry, microbiology, or related science.


Experience: Minimum three years related QA experience with a scientific background and solid understanding and knowledge of GMPs and Regulatory Guidelines

  • Individuals with equivalent combination of education, training, and experience will be considered.

  • Good general understanding of cross functions within departments, i.e. Technical Services, QC, Production.

  • FDA Regulations, GMPs, SOPs

  • Experience in performing quality complaint investigations

  • Knowledge of Annual Product Reviews

  • Independent use of computer with ability to learn new software

  • Problem Solving

  • Time Management

  • Statgraphics or similar statistical program



Primary Location
: United States-Pennsylvania-Sellersville
Work Locations
: Sellersville USA-650 Cathill Road Sellersville 18960,,,,,,,,,,,
Job
: Quality Assurance
Organization
: Pharma Solutions
Day Job
Job Posting
: 27-Jul-2021, 7:35:27 AM

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