Validation Specialist - GIPHARMA
AAA Italy Srl.
Saluggia, Italy
6 gg fa

AAA Statement Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics.

AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company.

We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal.

Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Major Activities :

  • Planning, managing and executing installations, operations and performance qualifications of packaging, production equipments and utility systems including the preparation of all the related documentation like protocols.
  • Scheduling, planning, managing and executing studies for clean validation and Cleaning and Disinfection including the preparation of all the related documentation like protocols. .
  • Scheduling, planning, managing and executing process validation studies and authoring related plans, final reports and protocols.
  • Reviewing and approving validation project documentation or any other related documentation in scope.
  • Coordinating and interfacing with the Manufacturing head & Supervisors, quality assurance, quality control, QP, PMO, aseptic specialist and engineering groups for assuring successful project execution.
  • Leading and coordinating cross-functional teams for project and activities validation.
  • Prioritizing, managing and executing multiple projects / activities utilizing the project management methodologies.
  • Overseeing and coordinating external validation resources / company that could be useful.
  • Supporting the development of best and proven validation practices in the validation department, based upon current industry guidelines and practices.
  • Authoring relevant standard operating procedures for ensuring compliance with the company’s policies.
  • Supporting regulatory submissions and also regulatory agency inspections whenever required.
  • Championing continuous improvements in the validation department.
  • Education :

    Bachelors’ degree in life sciences or engineering

    Languages :

    Italian - fluently spoken / written

    English - fluently spoken / written

    Professional requirements :

  • 4-5 years experience in a highly regulated environment like biotechnology, pharmaceutical or related fields, including a significant exposure to regulatory requirements.
  • Experience in project management and Manufacturing activities including quality and regulatory aspects
  • Excellent leadership and managerial skills.
  • Superb communication and interpersonal skills for coordinating between the various departments and staff of the company as well as the validation cell.
  • Knowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to time.
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