21 ago - Mirandola
Altro
About Us 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 Us 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. 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 Job You 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 equipment Preparation and review of validation protocols, reports and related documentation Coordinationn of qualification and validation activities, ensuring timely execution and documentation review Ensure compliance with GMP requirements and internal quality standards Support change controls, deviations, CAPAs, and risk assessments related to validation Collaborate with clients cross-functional teams (QA, Production, Engineering, QC) to support validation projects Maintain validation documentation and ensure the validated state of equipment and processes drafting Validation Master Plan risk analysisdrafting SOPs Required Skills And Experience Bachelor's/ Master's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline. 1-2 years relevant professional experience Exp riences in qualification and commissioning Writing 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.
Additional Skills
Attention to detail Team working Problem solving Good Interpersonal skills Flexibility and willingness to travel to client sites as required.
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