Lead Associate/Manager QA Data Reviewer
Company: Dr Reddy Laboratories LA LLC
Posted on: May 16, 2020
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
* 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
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
Didn't find what you're looking for? Search again!