Batch Record Reviewer

About the role

Join our mission to deliver a smoke-free future. This role is crucial for maintaining product quality and ensuring compliance with PMI and legal standards.

Responsibilities

• Perform critical review of executed batch production records while managing nonconformities and related corrective and preventive actions.
• Provide reports and technical support to relevant departments related to quality performance and product quality assessment.
• Ensure compliance with PMI and legal standards, policies, and environmental, Health, Safety, and Sustainability guidelines.
• Foster a proactive, safety-first culture using preventive and predictive approaches in line with our Integrated Operating System.
• Support the manufacturing team in establishing and revising batch documentation, guiding on data and record management.
• Support the monitoring of Quality Key Performance Indicators (KPI).
• Establish a system to identify and segregate non-conforming intermediate and finished products, investigate and resolve critical deviations, and define disposal and corrective actions.
• Implement a monitoring system of manufactured products through historical data and trend analysis to identify potential deviations and preventive actions (CAPA).
• Provide Quality support and expertise to improve products and Quality systems.
• Offer timely quality support in case of quality problems, providing quality risk assessment and an accurate action plan/solution to reduce negative impact on Quality and production KPI's.
• Support the implementation of quality standards and self-control systems to ensure products and processes meet quality requirements throughout the manufacturing line.
• Communicate all useful information for the good flow of Quality processes to concerned colleagues and support teams.
• Support Quality Engineers in defining new quality standards for new products.
• Execute internal training to manufacturing employees, serving as a subject matter expert in quality processes and products.

Requirements

• Education: Degree in Biological sciences, Physical sciences, Engineering or equivalent skills through demonstrated experience.
• Work Experience: 2+ years’ experience in FMCG production, quality or relevant skills through demonstrated experience.
• Experience: Working with manufacturing batch record documentation.

Qualifications

• Essential Skills: Team player with excellent communication skills and patience, knowledge of quality systems, data review, attention to details, advanced knowledge of Quality tools, root cause analysis, analytical skills, statistical tool knowledge, ability to transform data into information (reporting skills), knowledge of International Standards (ISO) and FDA cGMP requirements, experience in FDA regulated environment preferred.

Skills

• Ability to transform data into information (reporting skills).
• Advanced knowledge of Quality tools, root cause analysis, analytical skills, statistical tool knowledge.
• Knowledge of International Standards (ISO) and FDA cGMP requirements.
• Experience in FDA regulated environment preferred.

Benefits

We offer a competitive base salary and the potential for a discretionary annual bonus. Employees also have access to various benefits including medical, dental, and vision plans, as well as flexible spending accounts for health care and dependent care, and health savings accounts for high deductible health plans. Paid vacation, sick time, holidays, and other leave options are provided, along with life insurance, AD&D insurance, and disability insurance. Supplemental life and AD&D coverage is available for personal use. PMI is committed to an inclusive, diverse culture and offers opportunities for growth and development within a global business context.

Pay

$33.00 per hour

Schedule

Flexible work schedule to accommodate the needs of the role and the business.