Sterile Injectable Manufacturing Quality Expert

5 days ago


Mount Abu, Rajasthan, India beBeeQuality Full time ₹ 15,00,000 - ₹ 20,00,000
Quality Assurance Specialist

This role requires a meticulous individual with expertise in validation methodologies and regulatory guidelines.

Responsibilities:
  • Review and approve batch records, ensuring accuracy and compliance with regulations.
  • Collaborate with teams to resolve discrepancies and missing documentation.
  • Analyze electronic data for quality control purposes.
  • Verify product labels against specifications and standards.
  • Compile reports on product quality trends.
  • Evaluate change control proposals for potential impacts on validation and regulatory compliance.
  • Review deviation reports and track trends for periodic reporting.
  • Approve CAPA plans addressing identified issues.
Requirements:
  • Detailed knowledge of sterile injectable manufacturing processes.
  • Expertise in analytical techniques and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in quality management software.


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