Quality Assurance Engineer – Process and Validation

Position Summary

We are looking for a Quality Assurance Engineer who will be responsible in maintaining the company’s quality systems and oversight to ensure the product process validation, cleaning validation, Quality Risk Management and quality laboratory systems meet cGMP and the company’s compliance requirements in accordance to qualification, compliance, and business requirements.

Duties & Responsibilities

• Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
• Participate in Quality Risk Management and analysis and maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support product process transfers, including validation, from and/or to other manufacturing sites and other activities related to product introduction to the site.
• Support aseptic process simulations, quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, Annual Product Quality Review (APQR), and management notification.
• Provide quality review and support for laboratory method validation/verification and laboratory information management system (LIMS).
• Provide support to equipment, facilities and utilities qualification as needed.
• Work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions. Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Travel (up to 5%) may be required
  
  
  

Required Qualifications

• Bachelor’s degree in a scientific discipline with 4 years Quality/cGMP experience in the pharmaceutical industry.
• Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations and Quality Risk Management.
• Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
• Participation and leading activities to support regulatory agency inspections required.
• Project management, organization, and execution skills are required.
• Ability to apply technical expertise to solve problems and issues.
• Participating in and leading activities that support regulatory agency inspections is required.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
  
  
  

Preferred Qualifications

• Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.