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Regulatory Affairs Manager

8.00 to 13.00 Years   Bangalore   03 Apr, 2021
Apex Services
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryBPO / Call Center
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Roles and Responsibilities

  • Candidate will be responsible for RA related tasks to ensure that the company s activities are performed at the requisite quality and compliance level. Will improve and maintain the quality system.
  • Primary responsibility will be to write and execute Quality and Compliance related procedures and plans in close collaboration with the Quality Affairs Manager.
  • Review design & development related documents like SOPs, Technical file documents, and Validation documents.
  • Will organize, manage and execute internal and external audits in collaboration with the Quality and Regulatory departments.
  • Organize and provide quality related trainings.
  • Review analytical data for validation, incoming goods QC and batch release purposes.
  • Manage change control, document control, deviation and non-conformance handling.
  • Organize and manage thorough post-market survey procedures with close collaboration with the product manager and product support team.
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Keyskills :
batch releaseexternal auditchange controlproduct supportdocument controldesignsurveycontrolcomplianceregulatoryanalyticalvalidationcollaborationBatch RecordsCAPAsQuality InvestigationsOOSBatch ControlIPQA

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