IPQA Quality Specialist

5 days ago

Roorkee UL IN beBeeQuality Full time ₹ 7,00,000 - ₹ 8,50,000
Job Title: IPQA Quality Specialist

The IPQA Quality Specialist is responsible for conducting in-process inspections to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements. This role involves monitoring production processes, verifying batch documentation, and collaborating with production and quality control teams to optimize operational efficiency.

Main Responsibilities:

  • Conduct regular in-process inspections (IPIs) to verify adherence to GMP SOPs and regulatory requirements.
  • Monitor production processes including manufacturing, packaging, and labeling to identify potential issues.
  • Verify batch documentation including batch records, labels, and packaging materials to ensure accuracy and completeness.
  • Perform line clearance, room clearance, and equipment clearance to maintain a safe working environment.
  • Conduct regular audits of production areas, equipment, and processes to identify areas for improvement.
  • Investigate and address deviations, discrepancies, and non-conformities to prevent reoccurrence.
  • Collaborate with production and quality control teams to resolve issues and improve overall quality.
  • Review and approve batch records, SOPs, and other documentation to ensure compliance.
  • Participate in internal audits, customer audits, and regulatory inspections to demonstrate commitment to quality.
  • Implement corrective and preventive actions (CAPAs) to improve processes and reduce risks.

Requirements:

  • A strong understanding of GMP regulations and FDA/EU guidelines is essential.
  • Experience with auditing and inspection techniques, as well as root cause analysis (RCA) and CAPA implementation skills.
  • Proficiency in Microsoft Office and document management systems is required.

Preferred Qualifications:

  • Total work experience: 1 year.

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