13 ago - Parma
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 The Job
The job location is Parma, Italy, with a hybrid working policy. You will have ownership of the following activities supporting our clients' Qualification & Validation operations.
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
Coordination 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 analysis
Drafting SOPs
Required Skills And Experience
Bachelor's/ Master's degree in Engineering, Life Sciences, Chemistry, Pharmacy, or a related discipline.
3+ years relevant professional experience
Experience in Facility, Utility, and Equipment Qualification and Commissioning within a GMP-regulated environment.
Strong technical writing skills, with the ability to prepare clear, accurate, and compliant qualification and validation documentation
Experience in drafting qualification protocols, reports, SOPs, and other GMP documentation
Good understanding of GMP requirements and validation principles.
Proficiency in Microsoft Office 365 (Word, Excel,
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