GMP Compliance Auditor

2 weeks ago

Round Lake, Illinois, United States Ventura Solutions Inc. Full time

We are excited to announce an opening for a GMP Compliance Auditor on a contractual basis. This position is pivotal in ensuring adherence to the company's policies, regulatory requirements, and international standards. The GMP Compliance Auditor will work collaboratively across various departments to enhance the auditing capabilities within Quality Assurance, leveraging industry best practices and extensive expertise.

Key Responsibilities

  • Ensure adherence to the company's policies, regulations, and global standards.
  • Collaborate across different business units.
  • Enhance the auditing capabilities within the Quality Assurance team.
  • Conduct Quality Management System (QMS) compliance audits as a team member or lead when necessary.
  • Engage with all levels of internal management across various functions and business units.
  • Present audit findings and internal control evaluations through comprehensive reports and presentations.
  • Assess audit responses for sufficiency, including root cause analysis and promptness, and facilitate necessary corrective actions.
  • Address complex issues and escalate concerns through business and Quality Management channels.
  • Act as a cGMP consultant/subject matter expert, providing well-researched and substantiated opinions on intricate compliance matters.
  • Assist in the preparation for regulatory agency inspections and responses to external observations.
  • Uphold all organizational and professional ethical standards while actively promoting and overseeing compliance.
  • Support the continuous improvement of the audit program and compliance strategy.
  • Engage in special projects or investigations as required.
  • Lead compliance initiatives such as sharing best practices, facilitating QA councils for manufacturing facilities, and other quality enhancement projects.
  • Participate in Audit Program Management and audit risk assessment strategies.
  • Contribute to Site Risk Program management and drive improvements.

Qualifications

  • Bachelor's degree in a relevant scientific discipline; advanced degree is preferred.
  • In-depth knowledge of applicable global regulations and standards.
  • A minimum of 10 years of experience in auditing or site quality leadership within a pharmaceutical or medical device organization.
  • Demonstrated multitasking, project management, and execution capabilities.
  • Exceptional verbal and written communication skills, including presentation abilities.
  • Strong conflict resolution, interpersonal, and influencing skills.
  • Robust technical, analytical, judgment, and problem-solving abilities.
  • Capacity to foster relationships across functional boundaries at various levels, both internally and externally.
  • Able to independently make prompt, sound decisions with limited information and discern when to escalate issues.
  • Self-driven and capable of working independently within established timelines.
  • Proven familiarity with quality system software.
  • Good proficiency in Windows-based applications (e.g., Word, Excel, PowerPoint).

About Ventura Solutions Inc.

Ventura Solutions Inc. is a distinguished consulting, staffing, and training firm specializing in medical devices and combination products. Our extensive industry knowledge, combined with a talented workforce, positions us as the preferred partner for a wide range of projects. We seamlessly integrate into your team to manage projects of varying complexity. Additionally, we assist in sourcing, screening, and onboarding qualified candidates for temporary, temp-to-permanent, and permanent roles. Our mission is to accelerate product development, ensure compliance, and help build exceptional organizations.

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