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Lead Associate/Manager QA Data Reviewer

Company: Dr Reddy Laboratories LA LLC
Location: Shreveport
Posted on: May 16, 2020

Job Description:


Position at Dr. Reddy's Laboratories, Inc.

At Dr. Reddy\'s "Good Health Can\'t Wait"

By joining Dr. Reddy s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Support review and approvals of Analytical Method Validation, Laboratory investigations, Method Transfer protocols, reports and Change Controls. The Analytical date reviewer is responsible for providing Quality support to manage the laboratory compliance through, Risk assessment, monitoring Laboratory Quality Management System Performance and monitoring Data Integrity controls and Laboratory inspection readiness at Dr.Reddy s Shreveport site.

The Lead Associate/Manager QA Data Reviewer is responsible to ensure data accuracy and integrity by reviewing source data, summary reports and documentation from the laboratory.

This position will be based in Shreveport, Louisiana.

Job Duties And Responsibilities:

* Review and approval of laboratory quality events (investigations, CAPA and Change Controls) pertaining to products (under development and commercial) manufactured, developed at Shreveport in compliance with Dr. Reddy s requirements.

* Review and approve Method Validation, Method Transfer Protocols/Reports and instrument qualification documents in compliance with internal guidelines.

* Data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications as needed

* Review, Support and escalate OOS (Out of Specifications) events. Ensures Investigations are assigned to data or documentation, as appropriate prior to data verification is signed off.

* Responsible to discuss data interpretation with individual analysts and elevate, if necessary, to determine data disposition.

* Facilitates laboratory data or documentation corrections with analysts to ensure accuracy.

* Support in maintaining and updating relevant SOPs for data review and reporting as needed.

* Support Laboratory Inspection Readiness at site in coordination with Site QA.

* Support in Implementation and review of Data integrity and Data review controls and electronic data audit trails to ensure data integrity at DRL Shreveport sites.

* Review and approve Change Controls for commercial and products under development. 33499 Makes decisions and recommendations to resolve quality issues.

* Review stability protocols/reports for commercial and R&D products in compliance with internal SOPs and Regulatory guidelinesHands on experience with HPLC and GC including any computerized software required for the operation of the equipment or analysis of results.

The Ideal Candidate Will Have The Following Qualifications:

* Bachelor Degree in Chemistry or Biochemistry required or Bachelors in a relevant area of life science with work experience may be considered

* 3-5 years experience testing pharmaceutical products in a GMP regulated QC laboratory is required.

* Knowledge of QC laboratory test procedures, cGMP requirements, ICH/USFDA guidelines, raw material analysis, method validation guidelines, analytical method transfers, finished products and stability testing procedures.

* Ability to read and comprehend methods and other instructional documents such as SOPs.

* Attention to detail and the ability to perform and document work in an accurate and repeatable fashion.

* Good interpersonal skills that support working in a team environment.

Equal Opportunity Employer: Minorities/Women/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Keywords: Dr Reddy Laboratories LA LLC, Shreveport , Lead Associate/Manager QA Data Reviewer, Executive , Shreveport, Louisiana

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