Compliance Auditor 1

To ensure success as a Compliance Auditor, the candidate should possess in-depth knowledge of product standards and extensive pharmaceutical experience preferably in manufacturing, quality assurance, and/or cGxP auditing and demonstrated project management experience in leading cross-functional teams

Key Responsibilities 

• To ensure success as a Compliance Auditor, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or cGxP auditing and demonstrated project management experience in leading cross-functional teams.
• Prepare and execute internal self-inspections and supplier audits and issue reports.
• Follow up on post audit action tracking & progress.

• Assisting in implementing Internal Audit plans for all Grifols manufacturing plants.
• Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants.
• Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses.
• Peer Review of Audits Reports.
• Provide support prior, during and post inspections for external Regulatory Inspections, Customer Audits and Corporate Internal Audits.
• Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems.
• Keeping abreast of industry standards and regulations.
• All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
• Contribution to the continuous improvement of the Quality Management System is required.
• Other additional duties may be assigned by the Director Quality Audits from time to time if required.
• Ability to travel (up to 30%)

Key Competencies 

Skills: 

• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Effective influence management and conflict resolution abilities.
• Highly developed investigative and reporting skills.
• Effective organisation and time management skills.
• Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups. 

Abilities:   

• Ability to travel. (up to 30%)
• Ability to generate and/or maintain reports, databases and presentations using Microsoft Office.
• Flexible, able to adapt quickly to change in a fast-paced environment.

Qualifications Essential 

• Minimum Bachelor’s degree in a scientific discipline.
• Minimum of 5+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or cGxP auditing. 
• ASQ Certification as a Quality Auditor, Manager or Engineer a plus.
• Superior knowledge of U.S. cGMPs and FDA guidance.
• Experience in sterile manufacturing
• Superior knowledge of EU GMPs, Annexes and ICH Guidance’s and International Standards (Risk Management, ICH 8, 9, 10)

Desirable 

• Experience in SAP