Essential Functions

• Responsible for m aintaining, evaluating and improving the Carmel site Quality Systems and all associated documentation.
  
• Responsible for the review and approval of Batch Records.
  
• Monitor metrics or KPIs and communicate information and recommendations to Site Quality Head.
  
• Manage the Carmel site internal auditing program and perform internal audits.
  
• Perform effective and timely investigations of Complaints. Determine root causes and suggest appropriate CAPAs. Manage the Complaint system.
  
• Manage the Annual Product Review program; ensure that APRs are completed in a timely fashion.
  
• Perform effective and timely investigations of deviations. Determine root causes and suggest appropriate CAPAs. Manage the Investigations system.
  
• Manage the CAPA program, ensure that CAPAs are completed in a timely fashion.
  
• Approve incoming printed materials in the SAP system.
  
• Communicate with other departments to provide support and to coordinate activities.
  
• Identify and design new systems or programs to remain current with industry compliance trends regarding liquid dosages and components, environmental monitoring, cleaning validation, risk assessments, etc.
  
• Handle personnel responsibilities including payroll / attendance, performance reviews, disciplinary action, goals/objectives, rewards, coaching, training, etc.
• Appropriately document employees performance and provide corrective actions or training.
  
• Assist in the development and presentation of cGMP training to all employees.
  
• Assist in special projects or other tasks as deemed necessary based on personal qualifications, business needs and QA managements discretion.
  

Training Or Experience

• At least 5 years of quality assurance experience in a GMP-regulated pharmaceutical manufacturing site.
  
• Prior supervisory experience required, prefer at least two years of supervisory experience.
  
• Knowledge of GMP, USP/NF, ICH, and FDA guidelines and regulations.
  
• Excellent oral and written communication skills.
  
• Expertise in Microsoft Word and Excel, knowledge of SAP preferred.
  
• Strong troubleshooting and investigation skills.
  
• Demonstrated ability to work as part of a cross-functional team.
  

Education

• Minimum of a BS Degree
  
• Supervises/Manages
  
• Supervise QA Inspectors