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Company: INDSOFT
Contact Name: Susheel
Website: http://www.indsoft.com

Job Details: QA Manager with with Data, Integrity, Compliance & Reviewer Date: Feb 20 2019

Job Reference: 493008
Job Category: Pharmaceutical Jobs [ View All Pharmaceutical Jobs Jobs ]
Company Type Employer
Employment type: Full Time
Degree: Bachelors
Experience: 4 years
Location: Lake Forest, Illinois, 60045
Job Skills: Data, Integrity, Compliance, Regulatory, Data Reviewer,
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Job Description

Our client based out of Illinois seeking for QA Manager for 6 months contract to longer term.
Note: Need locals to Illinois – who are in and around 30- 40 miles from Illinois 60045 – will be a huge plus.
Can consider Green Card Holders / US Citizens


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.
DESCRIPTION
QA Manager of Data Integrity and compliance provides independent oversight to the data integrity program for the facility including data generation and review. Individual will work in a detail oriented, compliant manner to ensure the facility operations align with client policies and procedures as well as cGMPs and industry data integrity expectations. QA Manager of Data Integrity & Compliance will assist in hosting audits and tracking audit responses to ensure they are timely and complete. QA Manager of Data Integrity & Compliance reports directly to the Director of Quality Assurance. Manages, implements and coordinates quality assurance program to prevent or minimize risk to the integrity of data at the Decatur site.

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