Treffen Sie AbbVie auf der T5 JobMesse

Process / Cleaning Validation Project Manager (f/m)

Einsatzort: Ludwigshafen

Process  / Cleaning Validation Project Manager (f/m)

Process / Cleaning Validation Project Manager (f/m)

To coordinate the development and maintenance of the company’s validation program in compliance with all applicable

regulatory and AbbVie requirements.

  • Managing, co-ordination, implementation and active participation in the site Validation Program
  • Ensuring team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines as all times.
  • This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned.
  • Responsible for presenting and taking ownership of own area during regulatory inspections and corporate audits
  • Ensures all procedures/policies and guidelines are in compliance
  • This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.
  • Supporting Bulk Manufacturing and the site KPI’s

 

Responsibilities:
  • Ensure all computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
  • Co-ordination / direction and active participation in the validation of site equipment,facilities, utilities, processes and software in compliance with AbbVie policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance of the Validation Master Plans.
  • Generation/maintenance of Project Validation Plans.
  • Generation of validation protocols and final reports to cGMP standard.
  • Review / approval of all protocols and final reports.
  • Management of validation change control process.
  • Adheres to and supports all EHS standards, procedures and policies
  • Is a site SME on all Validation issues and provides guidance on same

We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.

An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.

Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.

 

 

Qualifications:

 

 

  • Pharmacist, Engineer (Master, Dipl Ing)
  • 3-5 years experience in pharma environment, especially manufacturing
  • Experience working in a cGMP environment. Familiarity with the Regulatory and QA issues surrounding the manufacture
  • Experience in Product Development, CTS or supervisory experience in a busy production environment
  • Judgement, initiative, concern for excellence, providing direction, technical skill & competence, teamwork & Problem analysis, driving the business
  • Good communication and motivation ability is required
  • Strong written and verbal communication skills
  • Fluency in English is requirement in order to communicate with required colleagues globally

     

     

    We are looking forward to your online application and ask that you state your salary and your earliest start date or notice period in your personal statement.

    AbbVie is characterized by diversity and internationality. We therefore welcome diversity among our applicants, in

    particular also chronically ill and severely disabled people.

     

AbbVie (NYSE:ABBV) ist ein globales, forschendes BioPharma-Unternehmen, das sich der Entwicklung innovativer Therapien für einige der komplexesten und schwerwiegendsten Erkrankungen der Welt verschrieben hat. Mission des Unternehmens ist es, mit seiner Expertise, seinen engagierten Mitarbeitern und seinem Innovationsanspruch die Behandlungsmöglichkeiten in vier Therapiegebieten deutlich zu verbessern: Immunologie, Onkologie, Virologie und Neurowissenschaften. In mehr als 75 Ländern arbeiten AbbVie-Mitarbeiter jeden Tag daran, die Gesundheitsversorgung für Menschen auf der ganzen Welt voranzutreiben. In Deutschland ist AbbVie an seinem Hauptsitz in Wiesbaden und seinem Forschungs- und Produktionsstandort in Ludwigshafen vertreten. Insgesamt beschäftigt AbbVie Deutschland rund 2.600 Mitarbeiter. Mit rund 29.000 Mitarbeitern weltweit vertreibt AbbVie Medikamente in mehr als 170 Länder.

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