Skills:- MS Office,QMS ISO 13485, ISO 9001,21 CFR 820, MDR 745.

 Job Responsibilities

• Review Product Data
  • Check new product batches, test outcomes, and formulas.
  • Make sure all lab steps match set quality rules.

• Handle Regulatory Filings
  • Write and check papers for drug applications and market approvals.
  • Keep files updated with changing government laws.

• Support New Product Launch
  • Work with R&D teams to scale up new product lines safely.
  • Create quality standards for pilot plant runs and test batches.

• Manage Compliance and Audits
  • Prepare documents for internal quality checks and external audits.
  • Fix any quality issues found during plant inspections. [1]

• Write Standard Operating Procedures
  • Create and update clear work instructions for staff.
  • Ensure team members follow current good manufacturing practices.