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Job Description

Batch Record Reviewer

UNLIMIT YOURSELF! Are you passionate about PMI’s future, its culture change being the success driver for the transformation and experiences people go through every day in PMI? Do you look for ways to grow in your job? If you want to challenge yourself, working in a dynamic & international environment, then apply now! We are currently looking for a: BATCH RECORD REVIEWER PMI has always been a leading company in the sector, but the time of transformation we are currently experiencing is quite exciting and is unprecedented. We are facing one of the greatest transformations in the history of fast-moving consumer goods, and the creation of a vision of a smoke-free future requires enormous courage, resourcefulness and motivation. THE OPPORTUNITY 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) Grade level from: 6-7 Recruiter: Rita Gherardi Contract Type: temporary (1year) 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. JOIN A GLOBAL MARKET LEADER Philip Morris International (PMI) is leading a transformation in the tobacco industry to create a smoke-free future and ultimately replace cigarettes with smoke-free products to the benefit of adults who would otherwise continue to smoke, society, the company and its shareholders. PMI is a leading international tobacco company engaged in the manufacture and sale of cigarettes, smoke-free products and associated electronic devices and accessories, and other nicotine-containing products in markets outside the U.S. PMI is building a future on a new category of smoke-free products that, while not risk-free, are a much better choice than continuing to smoke. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, PMI aims to ensure that its smoke-free products meet adult consumer preferences and rigorous regulatory requirements. PMI’s smoke-free IQOS product portfolio includes heat-not-burn and nicotine-containing vapor products. As of June 30, 2019, PMI estimates that approximately 8.0 million adult smokers around the world have already stopped smoking and switched to PMI’s heat-not-burn product, available for sale in 48 markets in key cities or nationwide under the IQOS brand. For more information, please visit www.pmi.com and www.pmiscience.com. Philip Morris Manufacturing & Technology Bologna is Philip Morris International's first center for personnel training and prototyping, industrialization, and large-scale production of potentially reduced risk products (RRPs).
  • Contract
    Full-Time
  • Location
    Crespellano, Italy
  • Department
    Science & Innovation
  • Remaining Openings
    2
  • Job ID
    20409
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