Crespellano, Italy





Job ID


BATCH RECORD REVIEWER - Philip Morris Manufacturing & Technology Bologna Be a part of a revolutionary change At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Wherever you join our crucial 47,000-strong Operations team, you’ll have the opportunity to make an impact. PMI’s shift from selling cigarettes to our new smoke-free products has changed the way we work. New products bring new challenges – in the way we source and buy raw materials, in the way we engineer and manufacture, and in our supply chain planning. Your ‘day to day’ As Batch Record Reviewer you will be part of our Quality department for Philip Morris Manufacturing & Technology Bologna S.p.A.. and will be reporting to the Team Leader Batch Release. The position will be based in Bologna. In your role, you will ensure that all relevant standards are respected along the manufacturing process and provide support to Quality and Production teams to analyze nonconformities and to identify improvement opportunities. You will perform critical review of executed batch production records while managing intermediate and finished product non conformities and related corrective and preventive actions held and ultimately confirms to the final approver that the product can be released for commercial manufacturing. You will also provide reports and technical support to relevant departments related to quality performance and assessment of the product quality in line with QMS procedures. A critical part of the job will be to ensure that instruments are calibrated and methods validated for the accuracy, precision and reliability of the analysis. You will also carry out calibration and collaborative test on instruments and materials (Raw Materials, Packaging, Finished Goods and semi finished) in order to monitor the instruments and materials performances. Finally, you will ensure the identification and management of identified nonconformities and related corrective & preventive actions and update and create PMI internal methods, procedures and work instructions in order to define, to improve and/or to standardize the Quality related activities. Execute Quality Reports to support the achievements of Quality related objectives. Specific responsibilities include: - Provide Quality support and expertise in order to improve products and Quality systems. Ensure timely quality support in case of any quality problems encountered on products, providing quality risk assessment and an accurate action plan/solution that immediately reduces the negative impact on the Quality and production KPI's. Provide on floor support in the implementation of quality standard and self-control system in order to ensure that the products and the processes meet the quality requirements all along the manufacturing line. - Provide support on report generation and data analysis, when required by ensuring the compliance and integrity of data. Participate/support the monitoring of the different Quality KPIs. - Establish a system to identify and segregate all non-conforming intermediate and finished products whether identified at warehouse, at laboratory, on the floor or post production. Investigate and resolve critical deviations, define disposal actions and when appropriate corrective actions. Define and implement a monitoring system of manufactured products through appropriate historical data and trend analysis to identify potential deviations and preventive actions (CAPA). Ensure execution and update of Quality reports - Propose and follow-up quality improvement ideas in production or other processes in Operations. Analyze the information and participate in small projects with influence on product quality. Ensure Change management process is followed in compliance with QMS requirements - Support the manufacturing team in the establishment and revision of the batch documentation, providing guidance on data and record management. Ensure manufacturing batch Record and Batch release documentation is accurate, complete, reviewed and archived in line with PMI guideline and QMS requirements to ensure confirmation that the product can be released for commercial manufacturing. - Communicate all useful information for the good flow of Quality processes to concerned colleagues and to support teams in order to meet productivity, quality. Provide support during product and process improvement test and new platform development. Support Quality Engineers to define new quality standards for new products. - Challenge all the standard process and products in order to propose productivity initiatives. Support the work team to plan the tests and the analysis needed availing herself/himself of the concept of: Total Quality, Lean Manufacturing and Total Productive Maintenance (TPM) - Execute internal training to manufacturing employees, as subject matter expert in quality process and product, in order to enhance their overall level of quality awareness - Promote and apply all rules concerning PMI Quality, environment, health and safety. Report all situations requiring actions in order to minimize or eliminate risks exposure to personnel, company assets and societal impacts and be in line with or ahead of any applicable Law requirements and Company standards Requirements & Skills: - Professional Technical School (laboratory) or equivalent skills through demonstrated experience - At least 1 year of experience in industrial field (experience in QA is a plus) - Knowledge of relevant standards (ISO), QA processes. Knowledge on statistical and analytical tools. Ability to transform data into information (reporting skills). - Ability to learn quickly, interact with teams and colleagues, and to act quickly to solve problems both individually and in team - Fluent in Italian, good knowledge of English (writing and understanding in particular) Recruiter: Silvia Amarù WHAT WE OFFER Our company offers you a new and fresh scientific perspective. Here, you will never stop exploring and discovering: competitive wage conditions and the chance at potentially unlimited growth, thanks to performance monitoring systems that merge the talents of persons with their professional aspirations and allow for a constant growth of different proficiencies. Philip Morris Manufacturing & Technology Bologna (PM MTB) PM MTB is Philip Morris International’s Center of excellence, worldwide recognized for prototyping, mass-volume production and employees’ training on smoke-free products. PM MTB employs more than 1000 employees and its production site of Crespellano is one of the most advanced manufacturing venues in Italy for technology innovation, competencies development and talent recognition. In 2019, Philip Morris Manufacturing & Technology Bologna has been awarded as Top Employer for the sixth year in a row. In the same year, was also granted the Equal Salary Certification certificate by the homonymous foundation to certify that men and women are paid equally for equivalent work. Bring us your curiosity and a desire to challenge the everyday and we’ll give you lots of responsibility. You’ll help us improve, inject innovation and create new ways of working. You’ll be solving supply chain problems that span the whole world: a smoke-free world.