Responsibilities:
• Apply Good manufacturing Principles in all areas of responsibility.
• Demonstrate and promotes the company vision.
• Maintaining current equipment and facilities qualification documentation.
• Perform impact analysis of changes to facilities and equipment.
• Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
• Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
• Drives continuous improvement to the site’s equipment and facilities qualification/validation program.
• Assist in the authoring of site procedures related to equipment and facilities as required
• Monitor the site’s calibration program.
• Monitor the site’s preventative maintenance program.
• Author qualification documents as required.
• Conduct all activities in a safe and efficient manner.
• Other duties may be assigned to meet business/compliance needs.
• Minimum Qualifications:
• Bachelors Degree.
• A minimum of 5 years in the pharmaceutical/related regulated industry.
• Experience with equipment and facilities validation Quality Systems.
• Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
• Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
• Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.
Preferred Qualifications:
• Good written and verbal communication skills.
• Thorough understanding of regulatory documentation requirements.
• Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
• Ability to work independently.
• Experience in Microsoft Word, Excel, and Power Point.
