Regulatory Affairs Executive

4 weeks ago

Madurai, India Aurolab Full time

Job Summary:


  • Ensure manufacturing process complies with standards.
  • Establish and update quality plans.
  • Establish and update quality assurance procedures and specifications.
  • Maintain and update quality assurance records.
  • Data analysis and continual improvement Complaints handling
  • Lead or participate in the investigation root cause determination of internal and external
  • complaints.
  • Initiate and implement corrective and preventive action.
  • Document the complaint investigation, CAPA and closure of complaints.
  • Direct and drive quality objectives.
  • Co-ordinate with production and R&D to identify realistic and impactful quality objectives
  • and focal for each objective.
  • Monitor the progress of each objective and aid focals to achieve the objectives.
  • Document and update the objectives
  • Internal quality audit and External audit
  • Ensure availability of documents at the time of audit.
  • Co-ordinate with regulatory team and fulfill the audit requirements.
  • Ensure timely closure of audit findings.
  • Prepare DMR for new products.
  • Co-ordinate with R&D team in preparation of documents such as quality plan, SOPs, Risk
  • analysis, MDD documents and technical specification etc.

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