QUALITY CONTROL SPECIALIST CHEMICAL AREA- Lisbon

Lieu: Portugal - Amadora

Fonction: Quality Management

Compagnie: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

Conditions pour les agences de placement

Votre profil

In this position, you are responsible oversee the quality control related topics within the context of the implementation of a new pharmaceutical production facility. You are responsible for working closely with the area management ensuring a suitable support to the new site, namely with the implementation of the new Quality Control Laboratory. Your responsibilities include:
  • Analytical methods transfer and validation: elaboration, review and approval of protocols and reports
  • Implementation of a rapid identification method for active ingredient, including analytical validation and preparation of support documentation for regulatory submission
  • Product sampling and testing in the scope of process transfer/ validation, analytical method transfer/ validation, routine (raw materials, packaging materials and finished product), and stability
  • Prepare and review documentation, statistical data analysis, according to the implemented systems, for internal use and for regulatory purposes
  • Participate in the Quality Systems implementation in the new site as LIMS and SAGE Key user (database management of QC equipment’s, consumables, raw materials, packaging materials, drug products and stability specifications, as applicable)
  • Participate in the implementation of the new Quality Control Laboratory (investments, contact with suppliers, resources, others)
  • Participate as requested to assure GMP/GDP inspection readiness on agreed timelines
  • Participate in the implementation, maintenance and continuous improvement of management systems – quality, environment and security
For this challenging position, we are looking for an hands-on and autonomous person bringing the following profile:
  • Master or PhD in Chemistry, Biochemistry, Pharmaceutical sciences or similar
  • At least 3 years’ experience in pharmaceutical industry within a quality control / compliance position
  • Strong understanding of GMP requirements
  • Excellent knowledge of different physical and physicochemical methods of analysis (such as HPLC, NIR, RAMAN, FTIR, Titrations, Viscosity measurements)
  • Previous experience with IT systems as SAGE, LIMS, LMS, TRACKWISE, eDMS, Minitab and Empower
  • Lean and Six Sigma Training (Green or Yellow belt)
  • Fluent in Portuguese with very good command in English both in oral and written conversation Knowledge in French and / or German are assets.

You hold strong communications skills and are able to communicate with all levels in the organization. Solving problems and coordinating multiple responsabilities are the challenges you like to take. You would describe yourself as very rigourous and methodical person, who perserveres to reach ambitious goals.

A propos de nous

Le Groupe Vifor Pharma, anciennement Groupe Galenica, est une entreprise Specialty Pharma mondiale qui se consacre à la recherche, au développement, à la fabrication et à la commercialisation de ses propres produits pharmaceutiques. Il est le partenaire de choix pour les solutions innovantes axées sur le patient. L’entreprise, qui entend devenir le leader mondial des traitements de la carence en fer et des affections néphrologiques et cardio-rénales, aspire à aider les patients du monde entier souffrant de maladies graves et chroniques à mener une vie meilleure et plus saine. Le Groupe Vifor Pharma possède des sites de production en Suisse et au Portugal, ainsi qu’un réseau dynamique de sociétés affiliées et de partenaires lui assurant une vaste couverture de marché dans le monde entier. L’entreprise affiche une présence mondiale en constante augmentation mais conserve de solides racines dans son marché d’origine, la Suisse.

Le Groupe Vifor Pharma est constitué de Vifor Pharma, de Vifor Fresenius Medical Care Renal Pharma – sa société commune avec Fresenius Medical Care –, de Relypsa et d’OM Pharma.

Pour plus d’informations, veuillez consulter notre site: http://www.viforpharma.com/fr/a-propos-de-vifor-pharma/qui-sommes-nous.

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Conditions pour les agences de placement