Formulation Assessment Supervisor
Mylan N.V.
Dublin,Leinster,IE
2d ago

For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people.

If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.

Here's how Formulation Assessment Supervisor will help :

  • Support new product introductions, working with internal and external teams to develop and transfer analytical methodologies.
  • This includes method development, optimization and / or validation.

  • Responsible for overseeing the development, approval and review of documentation, specifications, test methods and QC procedures for testing of new materials & finished products.
  • Develop and maintaining close relationships within the R&D laboratory, across the projects group and departments as well as constant reviewing and reporting of results to the project team.
  • Maintain comprehensive record of own work and the project analysts as required.
  • Troubleshoot methods / instrumentation / processes as required for new raw materials and finished product testing.
  • Ensure compliance with Regulatory, GMP / GLP requirements and any other relevant procedures (SOP, DLP).
  • Plan and design work programme for the Project analyst on a weekly basis to meet project deadlines.
  • Attain specific goals / targets agreed with Technical services manager.
  • Demonstrate good scientific judgment and initiative in achievement of defined objectives. Identify problems; bring possible solutions of problems to the Technical Services Manager and propose possible future course of action.
  • Overseeing training of laboratory analysts by projects analysts in QC for the testing of new raw materials and finished products transferred to Rottapharm IRL.
  • To ensure that the key company targets and initiatives are met in areas of responsibility.
  • Review and approve analytical paperwork generated by project analysts.
  • Providing technical guidance on analytical method development and optimization.
  • Make Our Values Your Values

    Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude.

    People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.

    Here are the minimum qualifications and essential functions for this position :

  • A degree, masters or Ph.D in Pharmaceutical or another related science discipline.
  • Minimum of 5 years’ work experience, within a similar role, in a cGMP environment.
  • Strong background in Formulation Development or Assessments or Site Transfers.
  • Proficient in operation and troubleshooting of a wide variety of Pharmaceutical Manufacturing Operations.
  • Experience managing or supervising a team.
  • Full understanding of cGMP requirements, ICH guidelines, Ph. Eur requirements along with EMEA guidance.
  • Effective technical writing skills.
  • Excellent interpersonal, leadership, communication (written and verbal), organisational and time-management skills are essential.
  • Strong attention to detail.
  • Good decision-making skills.
  • The ability to be self-driven and capable of working on own initiative.
  • Will be proactive and flexible.
  • Apply
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