Vaga de parceiro

Sr GMP Auditor - Santo Amaro / BA

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • Job Description Major accountabilities: Audit Planning: Develop and implement audit plans and schedules for GMP compliance.
  • Conduct Audits: Perform detailed audits of manufacturing processes, facilities, and documentation to ensure adherence to GMP standards.
  • Compliance Verification: Verify that all operations comply with regulatory requirements and industry best practices.
  • Report Findings: Document audit findings and prepare comprehensive reports outlining observations, non-compliances, and recommendations.
  • Corrective Actions: Collaborate with departments to develop and implement corrective actions for identified issues.
  • Training: Provide training and guidance to staff on GMP requirements and best practices.
  • Continuous Improvement: Identify opportunities for process improvements and contribute to the enhancement of quality systems.
  • Regulatory Updates: Stay informed about changes in GMP regulations and ensure the organization remains compliant.
  • Risk Management: Assess risks associated with manufacturing processes and recommend mitigation strategies.
  • Key performance indicators: Successful support of projects with agreed quality and delivery dates, passing of internal and external inspections.
  • Meet quality and timelines for all projects -Act in accordance with Novartis standards.
  • The number and severity of cGMP issues identified during internal and external audits -Year-end figures within budget; Successful coordination of departmental operational activities Compliance Rate: Percentage of audited processes and facilities found to be in compliance with GMP standards.
  • Training Effectiveness: Evaluation of the effectiveness of training sessions conducted, often measured through post-training assessments and feedback.
  • Repeat Findings Rate: Frequency of recurring issues identified in subsequent audits, indicating the effectiveness of corrective actions.
  • Stakeholder Satisfaction: Feedback from audited departments and stakeholders regarding the audit process and outcomes.
  • Minimum Requirements: Work Experience: Education: Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field.
  • Experience: Extensive 10 + y experience in GMP auditing, quality assurance, or regulatory affairs within the pharmaceutical industry.
  • Skills: Strong analytical skills, attention to detail, excellent communication and interpersonal skills, and proficiency in audit management software.
  • Certifications: Certification in GMP auditing or quality management is preferred.
  • Preferred Qualifications: Advanced Degree: Master's degree in a related field.
  • Technical Expertise: In-depth knowledge of GMP regulations and guidelines, and experience with electronic quality management systems (EQMS).

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado
 

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