04 ago - Mirandola
Productlife Group
ph3About Us /h3 pProductLife 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.
/p h3About Us /h3 pProductLife 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.
/p pWe are now seeking a Validation Specialist Associate to enhance and join PLG Center of Expertise Engineering (previousl y CP 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.
/p pThe job location is around Mirandola in Italy with a hybrid working policy.
/p h3About The Job /h3 pYou will have ownership of the following activities supporting our clients' Qualification Validation Opeeations: /p ul liPlan, execution,
and documentation of qualification and validation activities (IQ/OQ/PQ) for facilities, utilities and equipment /li liPreparation and review of validation protocols, reports and related documentation /li liCoordinationn of qualification and validation activities, ensuring timely execution and documentation review /li liEnsure compliance with GMP requirements and internal quality standards /li liSupport change controls, deviations, CAPAs, and risk assessments related to validation /li liCollaborate with clients cross-functional teams (QA, Production, Engineering, QC) to support validation projects /li liMaintain validation documentation and ensure the validated state of equipment and processes /li lidrafting Validation Master Plan /li lirisk analysisdrafting SOPs /li /ul h3Required Skills And Experience /h3 ul liBachelor's/ Master's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline.
/li li1-2 years relevant professional experience /li liExp riences in qualification and commissioning /li liWriting Skills (Sentence Structure and Construction, Clarity and Effectiveness,) /li liExperience in drafting qualification protocols, reports, SOPs, and other GMP documentation.
/li liGood understanding of GMP requirements and validation principles.
/li /ul h3Additional Skills /h3 ul liAttention to detail /li liTeam working /li liProblem solving /li liGood Interpersonal skills /li liFlexibility and willingness to travel to client sites as required.
/li /ul /p #J-*****-Ljbffr
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