Description Overview

Prepare and maintain validation protocols and validation standard operating procedures for Perrigo Infant Formula operations. Duties include development, execution, documentation, and monitoring manufacturing validation projects. Investigate the manufacturing and production processes and prepare corrective actions and/or revalidation studies. Coordinate with personnel from the other departments, such as Quality Assurance, Production, Technical, and Engineering to successfully execute and document the results of the validation projects or routine programs. Perform/manage annual CCP and OPRP testing as well as the annual cleaning verifications. Oversee all Computer System Validation protocol approvals and executions.

Scope of the Role

• Quality Guardianship: Ensure that routine validation work and project design and commissioning integrate the relevant Perrigo standards and relevant regulatory standards. Prepare validation studies and protocols final reports, on a timely basis. Validation scope includes, but is not necessarily limited to: process vessels, cleaning/sanitization, product and process line sterilization, automated/electronic control systems, manufacturing processes. Plan and execute multiple assigned validation activities simultaneously, which may include use of PCs monitoring, laboratory work environment as well as significant projects for new lines, new products process/facility/equipment modifications or process improvements. Support HACCP study, process flow and QMS reviews. Assist in the HACCP study completion on a timely basis.
  
• Quality Control Activities: Supports projects as Validation/Food Safety/Quality representative. Supports HACCP for the implementation and management of relevant food safety control measures. Prepare and maintain QA/Validation standard operating procedures. Develop and maintain compliance with Validation Master Plans. Follow Good Manufacturing Practices; report food safety and quality issues immediately.
  
• People and Know-How: For validation programs, develop the required training material, train and coach on the required elements to ensure that production will take place achieving the objectives defined for food safety and quality. Drive the development of competence of operators and promote quality awareness and commitment.
  
• Quality Auditing and Verification: Perform annual verification activities, including CIP and CCP/OPRP verifications. Support readiness for internal and external audits. Support Management of Change (MOC) as needed. Maintain compliance with regulations and refer to the Quality Management System on all related procedures and programs. Understand the food safety and quality aspects of the position.
  
• Quality Mastership: Support Continuous Improvement initiatives in the quest for zero defect. Support activities to achieve compliance with the Quality Management System requirements and other applicable instructions and standards. Identify non-conformance issues and coordinate Quality/Food Safety risk analysis.
  
• Performs other duties as assigned.

Experience Required

Academic Experience Required
Bachelor’s Degree in Engineering, Chemistry, Microbiology, or related field or equivalent work experience in a validation scientist role

Operational Experience

• Experience with validation responsibilities in food, pharmaceutical, or medical device field
• Minimum of 3-5 years of related Quality experience
• Experience in regulated food manufacturing environment with exposure to 21 CFR 117, lean manufacturing, FSSC22000/SQF regulations and preferred experience with 21 CFR 106/107 and 21 CFR 113.

SKILLS:

• Leadership and people development skills
• Local language and English language written and spoken
• Excellent written and oral communication skills, including report writing
• Ability to work independently and handle multiple priorities
• Proficiency with PCs and software such as Access; Excel; Word; PowerPoint;
• Technical writing ability in an FDA regulated industry and ability to translate technical / quality / compliance theory into practical application
• Demonstrated ability to lead projects and teams
• Working knowledge of production processes and equipment
• Analytical and problem solving skills
• Working knowledge of instrumentation and data collection