08 set - Reggio Emilia
Productlife Group
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
24 set - Milano
3240 Kyndryl Italia
24 set - Gaggiano
Ams Italy
24 set - Orta San Giulio
Cannavacciuologroup
24 set - Sommariva del Bosco
Bachecalavoro