09 ago - Medolla
Phibro Animal Health
ph3About Phibro Animal Health Corporation /h3 pPhibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals. /p pPhibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to Phibro’s revenues being in excess of $1 billion, we are supported by over 2,400 employees worldwide. /p pAt Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be. /p pIf you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions. /p pThe Quality Assurance Supervisor is an integral part of our Quality Assurance team based out of our Medolla, Italy site. /p h3Position Details /h3 h3Education /h3 ul liMaster's degree in a technical-scientific field (Pharmaceutical Chemistry, Medicine, Veterinary, Biology, Chemistry, Pharmacy) /li liEsame di stato is required /li /ul h3Experience /h3 ul liMinimum of 5 years’ experience in a similar role, ideally in a pharmaceutical manufacturing facility /li liStrong knowledge of GMP regulations and quality management systems /li liExperience with regulatory,
client and self-inspections audits /li liEligible for Qualified Person role /li /ul h3Responsibilities /h3 ul liEnsure effective monitoring of production processes according to European and Phibro Quality Standards and EU directives and regulations /li liEnsure the execution of periodic reports (Product Quality Review) on the manufactured products and the GMP self-inspection /li liManage deviations (generation, investigation, impact, reporting and approval) /li liReview of Quality Control (QC) out-of-specification results and investigations /li liReview of quality acceptance criteria for raw materials, intermediates products, and finished products /li liCoordinates and manage periodic audits with Regulatory and Health Authorities /li liEnsure that all SOPs and other related documents follow GMP and Phibro Quality Systems; responsible for site GMP documentation control /li liProvide quality direction and manage the implementation of changes for critical company systems, according to the “change control” procedure /li liManage non-conformities, ensuring the quality of the finished product and verifying the efficacy of the corrective actions /li liManage customer complaints with related investigation, corrective activities, response and complaint closure /li liCoordinate activities to support the management of supplier qualification and approve the related Quality Agreement (where necessary)
/li liReview and approve qualification/validation protocols and reports /li liKnowledge of root cause analysis methodology and Quality Risk Management /li liCollaborate in the supervision of the general hygiene conditions of the premises and pest monitoring activities for which the supervisor is responsible /li liProvide information for, and complete, as necessary customer by mail surveys, audits, and inquiries /li liAs Qualified Person, ensure compliance with Regulation (EU) 2019/6 on veterinary medicinal products, applicable EU GMP requirements, marketing authorizations, manufacturing authorizations, and relevant national implementing legislation /li liProvide quality oversight of feed additive manufacturing activities and ensure compliance with applicable feed and feed-additive regulations, site licenses, and quality standards /li liEnsure appropriate segregation between veterinary medicinal product GMP activities and feed additive quality requirements where applicable /li /ul h3Core Competencies /h3 ul liExcellent problem-solving and decision-making skills /li liGood team building and collaboration both on-site and with teams remotely /li liPromote a culture of continuous learning and development for the site quality organization /li liImprove on-site understanding of GMP’s through good quality programs, procedures, and training /li liAbility to prioritize different activities and manage multiple projects /li liStrong communication skills /li liFluent in spoken and written English and Italian /li /ul h3Equal Opportunity Employer /h3 pAll qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law. /p h3Business Unit: Animal Health Mineral Nutrition /h3 pDivision: Animal Health Nutrition /p pDepartment: Quality Assurance /p pLocation: Medolla, Italy /p pWork Schedule: Monday - Friday (40 Hours) /p /p #J-18808-Ljbffr
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