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QC Stability Data Analytics

2.00 to 7.00 Years   Mumbai City   17 Jun, 2019
BVR People Consulting
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Position: Stability Data Analytics - QC Designation: Associate I or II Qualification: BSC. Degree or Diploma in a Life Sciences or related discipline. Years of Experience: 3 - 6 Years Roles & Responsibilities:

  • Prepare, review and publish Stability Summary Reports within compliance time frame.
  • Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers.
  • Review Stability data from third party affiliates for compliance.
  • Perform Stability Impact Assessment for out-of-trend results obtained at release for drug product as per approved procedures.
  • Perform shelf life extensions or reductions for product as required and as per approved procedures.
  • Perform trend analysis as requested by the customers and as per approved procedures.
  • Review and evaluate Stability data for the product to ensure that no significant trends are developing that warrants attention and that the approved shelf life continues to be justified.
  • Interpret statistical analysis from NWA.
  • Provide Annual Stability Review contribution packages to QA Product Review group for the Annual Product Quality Review (APQR). Notify Team Leader of any adverse trends detected.
  • Works as an effective team member to meet department goals, sharing knowledge with team members.
  • Maintain compliance to all health and safety standards, Good Manufacturing Practices, Good Documentation Practices and regulatory requirements. Responsible and accountable for compliance with all aspects of the local safety regulations, as well as XYZ Health and Safety policies, and Safe Work Procedures.
  • Performs all work in support of our Corporate Values of Courage, Collaboration, Pride and Perseverance; Demonstrates strong and visible support of our values.
  • Initiate Change Control Records for shelf life extensions/reductions, SOPs as necessary.
Interested & Eligible candidates kindly send your resume to sathish@bvrpc.com Or you can call, Or you can whatsApp to : 7676336386Salary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical ResearchFunctional Area: Production, Manufacturing, MaintenanceRole Category: Production/Manufacturing/MaintenanceRole: Quality Assurance/Quality Control ManagerEmployment Type: Permanent Job, Full TimeKeyskills: Data Analytics stability stability studies qc quality control publish Stability Review Stability Perform Stability evaluate Stability apqr stability data stability study ,

Keyskills :
researchlinicalpharmacontrol

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