09 ago - Mirandola
Productlife Group
About Us
Se è interessato/a a candidarsi per questo lavoro, la preghiamo di assicurarsi di soddisfare i seguenti requisiti, elencati di seguito.
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:
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- 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
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- 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. xysqume
Additional Skills
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- Attention to detail
- Team working
- Problem solving
- Good Interpersonal skills
- Flexibility and willingness to travel to client sites as required.
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