Validation Documents Internship
GSK
Toscana
6 gg fa

Your Responsibilities : Daily activities :

Daily activities :

1) Obsolete documentation gap assessment.

  • identify documental misalignment between effective GLIMS phases and analytical method validation
  • 2) Analytical method validation range verification.

  • identify method validation without specified validated range.
  • calculate the validated range
  • verify the calculated range against specification limits and process validation limits.
  • 3) Risk Assessment on sialic acid solutions.

  • verify intermediate precision and accuracy for all phases involved in sialic acid test.
  • assess most critical phases based on the results of the verification above.
  • 4) Analytical method validation of ON HOLD products.

  • identify the validation report on ON HOLD products (e.g. HIB, GBS etc )
  • Competencies acquired at the end of this experience :

  • 360 knowledge of QC organization. Interaction with several departments (QC lab, other AS&T members)
  • Analysis of data and knowledge of Analytical validation methods used in biological process for vaccine production.
  • Work in a team, respect strict timelines, report results periodically to upper management.
  • Basic qualifications :

  • Collaborative approach and ability to interact with other group members
  • Dynamic and pro-active attitude
  • Good (o Excellent) communication skills
  • Good English knowledge
  • Technical Knowledge of Microsoft Office, with focus on Excel and Power Point.
  • Preferred qualifications :

    Why GSK? :

    At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-

    leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy.

    To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.

    Important notice to Employment businesses / Agencies

    GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

    All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

    The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

    In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

    GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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