23 set - Mirandola
Productlife Group
About UsSe è interessato/a a candidarsi per questo lavoro, la preghiamo di assicurarsi di soddisfare i seguenti requisiti, elencati di seguito.ProductLife Group (PLG) is a dedicated life sciences and pharmaceutical outsourcing and consulting company providing expertise and services in areas such as: Product Development, Market & Patient Access, Regulatory Affairs and Safety & Vigilance as well as Engineering and Digital Transformation.The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC.About UsProductLife Group (PLG) is a dedicated life sciences and pharmaceutical outsourcing and consulting company providing expertise and services in areas such as: Product Development, Market & Patient Access, Regulatory Affairs and Safety & Vigilance as well as Engineering and Digital Transformation.The group has its HQ in Paris and affiliates around the globe with teams in all key regions: North America, Europe and APAC.We are now seeking a Validation Specialist Associate to enhance and join PLG Center of Expertise Engineering (previousl y C&P Engineering). Our Center of Expertise, is a multidisciplinary engineering and consulting firm specializing in providing tailored solutions for the pharmaceutical, medical, nutraceutical, and cosmetics industries in areas such as Engineering, Construction,
Qualification & Validation as well as Energy & Waste Management.The job location is around Mirandola in Italy with a hybrid working policy.About The JobYou will have ownership of the following activities supporting our clients' Qualification & Validation Opeeations:Plan, execution, and documentation of qualification and validation activities (IQ/OQ/PQ) for facilities, utilities and equipmentPreparation and review of validation protocols, reports and related documentationCoordinationn of qualification and validation activities, ensuring timely execution and documentation reviewEnsure compliance with GMP requirements and internal quality standardsSupport change controls, deviations, CAPAs, and risk assessments related to validationCollaborate with clients cross-functional teams (QA, Production, Engineering, QC) to support validation projectsMaintain validation documentation and ensure the validated state of equipment and processesdrafting Validation Master Planrisk analysisdrafting SOPsRequired Skills And ExperienceBachelor's/ Master's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline.1-2 years relevant professional experienceExp riences in qualification and commissioningWriting Skills (Sentence Structure and Construction, Clarity and Effectiveness,)Experience in drafting qualification protocols, reports, SOPs, and other GMP documentation.Good understanding of GMP requirements and validation principles. xysqume Additional SkillsAttention to detailTeam workingProblem solvingGood Interpersonal skillsFlexibility and willingness to travel to client sites as required.#J-18808-Ljbffr
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