QA Executive (API)

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QA Executive (API)

work outline icon5 - 7 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Nagindas Hiralal Bhayani

time outline iconBharuch, Gujarat, India

Posted on 18-03-2024

13 Views

1 Vacancy

Description

  • Implement and maintain the company's quality management system (QMS) to ensure compliance with relevant quality standards, regulations, and customer requirements.
  • Conduct internal audits to assess compliance with quality standards, identify areas for improvement, and implement corrective and preventive actions (CAPA) as necessary.
  • Assist in the development, implementation, and maintenance of quality procedures, work instructions, and documentation to ensure consistency and compliance with quality standards.
  • Review and approve quality-related documents, including batch records, test results, and quality reports, to ensure accuracy, completeness, and compliance with quality requirements.
  • Investigate quality issues, non-conformities, and customer complaints, and lead root cause analysis to identify underlying problems and implement corrective actions to prevent recurrence.
  • Monitor and analyze quality metrics and key performance indicators (KPIs) to track quality performance, identify trends, and drive continuous improvement initiatives.
  • Provide guidance and support to cross-functional teams on quality-related matters, including product development, manufacturing processes, and regulatory compliance.
  • Conduct supplier audits and assessments to evaluate the quality of materials, components, and services procured from external suppliers, and ensure adherence to quality requirements.
  • Coordinate with regulatory affairs team to ensure compliance with applicable regulations and standards, and support regulatory submissions and inspections as needed.

Category

Pharmaceuticals

Functional Area

Pharma Quality Assurance (QA)

Preferred Education

MSc (Master of Science)MPharm (Master Of Pharmacy)BSc (Bachelor of Science)BPharm (Bachelor Of Pharmacy)

Key Skills

Analytical SkillsAttention to DetailRegulatory ComplianceQuality AuditingDocumentation

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