Sr GMP Auditor

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).

Languages :

• English, Spanish, Portuguese