Stability Studies Responsible
Targu-Mures, Romania
2 zile în urmă

Job Description

  • This is the number of countries you will be cooperating with.
  • Sandoz Romania contributes to improving patients' accessibility to high quality treatment, through innovative solutions, in the conditions of increasing healthcare needs.

    Your Key Responsibilities :

    Your responsibilities include, but not limited to :

  • Collects stability data and centralizes them in accordance with customer requests and guidelines.
  • Responsible for the management of test instructions, ensures their preservation in a traceable manner, so that they are available for processing.
  • Prepares and as appropriate, reviews stability reports or other specific documents related to product stability
  • Provides specialized support for preparing, reviewing, sending the vital documentation for the annual product evaluation, participates in the investigation of deviations.
  • Throughout the operation, it is obliged to rigorously maintain the confidentiality of data and information regarding the activity of Sandoz, not being allowed to transmit them to other person outside the company or to use them in personal interest.
  • Responsible for product quality and compliance with GXP, including adequate reporting to higher levels of any issues related to product quality, incidents or GxP nonconformities.
  • Responsible for reporting to the management any activities that have the potential to compromise the operation of the quality system or product quality, in accordance with the Quality Directive on Critical issue in the Novartis Quality Manual.
  • Responsible for the accuracy and completeness of the completed documentation.
  • Minimum requirements

    What you’ll bring to the role :

  • Education : Higher education, Faculty of Pharmacy, Chemistry, Medicine, Biology.
  • Proficient Romanian and English (spoken & written).
  • Observation skills and attention to details.
  • Conscientiousness and meticulousness.
  • Willingness to learn
  • Desirable Requirements :

  • Min. 6 months of experience in the pharmaceutical industry, drug control.
  • Knowledge of Quality Control and Assurance, Production in the pharma industry; GMP knowledge, quality standards, applications and digital tools.
  • Why Sandoz?

    million patients were touched by Sandoz generic and biosimilar medicines in and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

    How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation.

    That a diverse, equitable and inclusive environment inspires new ways of working.

    We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility.

    And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges.

    Because the greatest risk in life, is the risk of never trying!

    Imagine what you could do here at Sandoz!

    Commitment to Diversity & Inclusion :

    Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

    Join our Novartis Group Network :

    If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here :

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