Register Here to Apply for Jobs or Post Jobs. X

QC​/QM- Manager Integrity, Compliance, Regulatory & Laboratories

Job in North Chicago - IL Illinois - USA
Posted by Susheel
Full Time position
This Job Posting has Expired
Job specializations:
  • Quality Control
    QA Manager, Quality Control Manager, Quality Manager
  • Laboratory/Lab Tech
    Laboratory Assistant
Job Description & How to Apply Below
Position:  QC/QM- Manager with Integrity, Compliance, Regulatory AND Laboratories
QA Manager with Data, Integrity, Compliance & Reviewer --- Lake Forest, IL – Full Time

REQUIRED EXPERIENCE: (5+ - 7 Years in the following areas)
• Required developing and maintaining Data Integrity System for the site, including ownership of Data Integrity SOPs, development with Audits data from Quality Control Laboratories (Chemistry and Microbiology)
• Required experience in investigation of discrepancies in Quality Control Laboratories. And Performs reviews of site NDA/ANDA filings
• Required Commercial and ANDA stability programs. And administration of GMP-IT Systems (Computerized data systems)
• Required experience in review/close out any aborted or rejected batch records. / And review/close out any non-commercial (ANDA Exhibit, Engineering etc) batch records. / And review/close out all media fill batch records.
• Required providing data from batch record review and stability reports for analysis during annual product reviews.
• Required experience in reviewing method validation/verification and transfer protocols and final summary reports/data.
• Required previewing process validation/verification protocols and final summary reports/data.
• Required review validation qualification and requalification protocols and final summary reports/data.
• Performs pre and post review/approval of change controls and associated action plans/validation activities.
• Assist in hosting, Internal, Customer and Regulatory Agency. And conduct routine Data Integrity related training.
• Provides and tracks responses to audit observations and deficiencies.
Position Requirements
Bachelor,   7 to 8 Years work experience
Data, Integrity, Compliance, Regulatory, Data Reviewer, Quality Control Laboratories,
Required Language Skills:
  • English - Very good
Search for further Jobs Here:
Location Job Location
Employment Category Job Category
Education (minimum level)
LOGIN Area - Jobsite