15 ago
|
Productlife Group
|
Parma
15 ago
Productlife Group
Parma
About Us Product Life 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, Power Point, Outlook).
Additional Skills
Strong attention to detail and commitment to quality Team coordination or leadership experience Excellent teamwork and collaboration skills Strong analytical and problem‐solving abilities Good interpersonal and communication skills Client relationship and stakeholder management experience Flexibility and willingness to travel to client sites as required
📌 Validation specialist officer (senior role)- parma area italy
🏢 Productlife Group
📍 Parma