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Officer/ Senior Officer Quality Assurance API

2.00 to 6.00 Years   Ahmedabad   13 Feb, 2020
Dishman Group
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  • Responsible for C omputer System Validation
  • Responsible for C ontrol of all Master documents.
  • Review of completed B atch Production Records for manufactured intermediates and APIs and laboratory control records before release of the API for distribution. Release of API for distribution.
  • Preparation of Standard Operating Procedures.
  • Review & approval of Standard Operating Procedures related to other departments.
  • Review & approval of qualification protocols & reports. Assigning deviation and change control numbers. Review & approval of Change Controls, Deviations and Out Of Specification Investigations .
  • Making sure that effective systems are used for maintaining and calibrating critical equipment.
  • Responsible for internal audits (self-inspections) at site.
  • Responsible for updating CAPA and quality matrix.
  • Participate at customer and Regulatory authority inspections .
  • Responsible for conducting surprise checks to assess SOP vs practices at site.
  • Responsible for review of automation system like QC audit trail, production automation system audit trail, automated QMS, ERP , etc.
  • Conducting training sessions of GMP awareness training, SOP training to newly joined employees. Support QA Head in the Implementation and maintain of cGMP at Site.
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Keyskills :
bankingsales customer servicemis accountsstandard operating procedures audit trailsystem audit

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