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Stellenangebot: Manufacturing Head, Project Manager und QA Specialist/associate

Das Unternehmen Orgenesis Austria GmbH ist auf der Suche nach einem Manufacturing Head, Project Manager und QA Specialist/associate.

Die Details zum Stellenangebot:

PROFILES:

Orgenesis Austria GmbH offers an entrepreneurial, progressive, and collaborative environment. Whether you work in the lab, in an office or on the production floor, the objective is the same — to improve lives. We would be proud to foster and support your personal and professional development as a member of our Team. Locations: Austria/ AT

 

Categories: Manufacturing Head

  • Master’s Degree in Biochemistry
  • Microbiology
  • Biotechnology or Chemistry
  • and 5 years of experience in Biopharmaceutical Industry

You will:

    • Supervise daily routine activities in Manufacturing department. Responsible for review of cGMP documents like SOPs, qualification and validation protocols etc. related to the Process, Equipment and Facility
    • Identify and address operational and maintenance issues to prevent delay in production.
    • Monitor all the routine manufacturing operation with relevant cGMP requirements.
    • Participate in QMS activities (e.g., Change Control, Deviations, Market Complaints)
    • Manage departmental employees (team) performance reviews and appraisals.
    • Recruit new employees, Interviewing, hiring and training.
    • Responsible for the employee’s retention and development.
    • Optimize production operations within the prescribed controls, to meet quality and performance standards.
    • Address employee concerns and complaints in professional manner.
    • Analyzing overall budget and implementing cost-optimization initiatives.

 

Categories: Project Manager

  • Master’s Degree Immunology/Chemistry/Biochemistry/Microbiology, or equivalent work experience
  • and 5 years of experience in Project Management

You will:

    • Coordinate internal resources and third parties/vendors for the flawless execution of projects.
    • Ensure that all projects are delivered on-time, within scope and within budget.
    • Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
    • Ensure resource availability and allocation.
    • Develop a detailed project plan to monitor and track progress.
    • Oversee all aspects of projects.
    • Manage changes to the project scope, project schedule and project costs using appropriate verification techniques.
    • Measure project performance using appropriate tools and techniques.
    • Report and escalate to management as needed.
    • Manage the relationship with all stakeholders.
    • Perform risk management to minimize project risks.
    • Establish and maintain relationships with third parties/vendors.
    • Create and maintain comprehensive project documentation.
    • Meet with clients to clarify specific requirements of each project.
    • Delegate project tasks based on junior staff members‘ individual strengths, skill sets and experience levels.
    • Track project performance, specifically to analyze the successful completion of short and long-term goals.
    • Meet budgetary objectives and make adjustments to project constraints based on financial analysis.
    • Develop comprehensive project plans to be shared with clients as well as other staff members.
    • Use and continually develop leadership skills.
    • Attend conferences and training as required to maintain proficiency.
    • Perform other related duties as assigned.
    • Develop spreadsheets, diagrams and process maps to document needs.

 

Categories: QA Specialist/associate

  • Master’s/ Bachelor’s Degree in Biochemistry, Microbiology, Biotechnology or Chemistry
  • 1-3 years of experience in a similar role in Biopharmaceutical Industry

You will:

    • Documentation: Preparation, review of QMS Documents (e.g., SOPs, validation protocols, reports).
    • Ensure Management of Change Control, Deviations, CAPA and Trainings are initiated, documented, reviewed and approved in a timely and comprehensive manner.
    • Participate in Validation Activity (e.g., facility, process equipment and clean utilities).
    • Participate in Internal Audit Programs within the organization.
    • Participate in Qualification of various vendors impacting product or process quality.
    • Participate in Quality investigations (e.g., OOS, CAPA, Deviations).

 

Equal Employment Opportunity

At Orgenesis Autria GmbH, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Weitere Informationen zu den einzelnen Stellenangeboten und die Möglichkeit zur Übermittlung der Bewerbung finden Sie hier: https://ir.orgenesis.com/careers

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