Job Description

• Review and approve Deviation Investigations, Complaint Investigations, CAPA and CAPA Effectiveness Checks to ensure all information contained within is accurate per applicable reference documents and also complies with all SOPs and customer requirements.
• Coordinate necessary clarifications or corrections with responsible Investigations and CAPA owners to ensure timely and accurate completion.
• Review and approve Change Controls, Action Items and Change Control Effectiveness Checks to ensure all information contained within is accurate per applicable reference documents and also complies with all SOPs and customer requirements.
• Coordinate necessary clarifications or corrections with responsible Change Control owners to ensure timely and accurate completion of change controls.
• Identify and drive continuous improvement to the site's Deviation Management, Change Control and CAPAs processes.
• Conduct all activities in a safe and efficient manner.
• Other duties may be assigned to meet business/compliance needs.

Knowledge, Skills, Abilities

• A minimum of 5 years in the pharmaceutical/related regulated industry
• Experience with Investigation Management Quality Systems (e.g. deviation complaints).
• Experience with Change Control and CAPAs.
• Must be detail oriented to detect errors or deficiencies with investigations.
• Possess the ability to use sound judgment in discerning if documentation accurately and completely reflects the documentation and requirements of the investigation.
• Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
• Good written and verbal communication skills.
• Thorough understanding of Root Cause Analysis.
• Thorough understanding of regulatory documentation requirements.
• Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
• Ability to work independently.
• Familiar with or experience in Microsoft Word, Excel, Power Point, and TrackWise.
• Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.