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Validation Specialist Officer (Senior Role)- Parma area Italy

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.

We are now on the look out for an experienced Validation Specialist Officer 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 Parma 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 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, PowerPoint, 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
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Offerta di lavoro pubblicata 2 giorni fa
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