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NVision Imaging Technologies logo
NVision Imaging Technologies

Leveraging quantum technology to enable imaging of cell metabolism via hyperpolarized MRI

Validation Manager, Pharmatech Industry

ManagerManagerFull TimeRemoteSeniorTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

Germany

Posted

66 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Validation Manager, Pharmatech Industry

NVision Imaging Technologies

• Reporting to the Senior Director of Quality, the Validation Manager will have responsibility to develop and manage all validation activities under the Quality Management System • Provide expert advice on the validation strategy for development programs • Develop and maintain the Validation Master Plan (VMP) • Develop systems, processes, tools and templates for the conduct of qualification and validation activities • Work cross functionally to develop qualification and validation protocols in accordance with the requirements of the VMP • Review and approve qualification and validation reports • Project Management of validation activities • Initiate and manage deviations, changes and risk assessments in the conduct of validation activities • Quality oversight of the stability program • Quality oversight and support for technical transfer activities • Support the ongoing continuous improvement of the company’s QMS in compliance with applicable GxP requirements and regulatory guidelines • Lead by example in promoting and facilitating a quality culture • Work cross functionally to provide quality oversight, support and expertise in the conduct of quality related activities across development projects, employing Quality by Design (QbD) principles • Provide training to staff on quality topics • Support the conduct of quality investigations and initiatives • Prepare, manage and present materials for Quality Management Review

Job Requirements

  • At least 5 years of hands-on experience of validation in a GMP sterile manufacturing environment, ideally in a development setting
  • Strong understanding of and experience of GMP requirements in the EU and US and sound knowledge of applicable ICH guidelines
  • Demonstrated expertise in the management of validation activities
  • Experience of method validation, process validation and equipment qualification
  • Experience of Computer System validation is an advantage
  • Excellent problem-solving, analytical, and communication skills
  • Familiarity with electronic Quality Management Systems (eQMS)
  • Fluent in English

Benefits

  • Attractive compensation package, including a competitive base salary and stock options
  • Key role in a highly advanced and fast-growing startup company
  • Impactful product promoting better understanding and treatment of cancer
  • International team, from over 30 different nationalities
  • Positive work environment with open communication and a collaborative mindset
  • Onsite work at state-of-the-art facilities with home-office opportunities
  • Hybrid model
  • Indefinite employment contract
  • 30 vacation days
  • Flexible working hours
  • Annual health budget (Allianz bKV)
  • EGYM Wellpass
  • Relocation support

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