QUALITY OPERATIONS SUPPORT SPECIALIST (H/F) (Suisse)

Présentation de l'entreprise

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Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

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Descriptif du poste

- Review batch records for accuracy and compliance to procedures, and release or reject as appropriate
- Evaluation of results in terms of acceptability to standards, procedures and regulatory requirements
- Perform evaluation of non-conformities, investigate and define corrective/preventive actions in a timely manner
- Change control: function as Change Agent and conduct analysis of written procedures and their application in Operations.
- Evaluates and approves new or revised documents for accuracy. - Identifies areas of improvements
- Support other functions as a technical expert for problem solving - Manage databases
- Quality in Operations : Acts as a Quality-link on the floor to support adequate quality system deployment and application
- Reports any potential issues detected on the floor and proposes adequate Preventive Actions
- Establishes efficient partnership with Production people to define and review detailed action plan for any process modification or improvement
- Participate to internal or external assessments, as required.
- Support process with timely closure of observations/audit items
- Follow and report the quality indicators of the quality system of the area. - Participate to and support facility projects.
- Review validation protocols.
- Provide training to the quality department employees as areas are identified (e.g. GDP, SOP, QLP, QA database, etc.)

Profil recherché

- Minimum Bachelor of Science.
At least 3 years of experience in pharmaceutical industry (preferably in the aseptic or biotechnology field)
- Excellent understanding of regulatory requirements
- The incumbent should have the following skills and knowledge: CGMP and regulatory requirements working knowledge
- Fluent in French (good writing skills) and good knowledge of English (written and spoken)
- Good computer skills (MS office) Good communication and negotiating skills
- Good organizational skills (precision and rigor)
- Good analytical skills Good problem solving skills
- Responsible.

Veuillez postuler en ligne via le formulaire ci-dessous en précisant le numéro de référence PAPR65268.
Votre candidature sera transmise à Amandine Paraz.

Page Personnel

Référence : TJOB633377
Localisation : Suisse - Neuchatel
Type de contrat ou durée de la mission : CDI
Rémunération : N.C.