Quality & Safety Investigator (m/f/d)

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Beschreibung


  • You will work for an American multinational biotechnology company specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide

Quality & Safety Investigator (m/f/d)

Reference: -en
Start: ASAP
Duration: 6 MM

Main tasks:
  • Leads investigations for Quality deviations and incidents. Conducts Quality investigations with focus on performance improvement and risk reduction, in alignment with Quality Management System requirements and governing safety regulations. 
  • May support complex and/or high impact investigations. 
  • Identifies root and contributing causes and makes recommendations to correct and/or prevent recurrence.
  • Documents investigation reports and findings in designated Quality systems. 
  • Ensures required management and Quality approvals on final investigations while satisfying established due dates. 
  • Facilitates corrective and preventive action agreement with stakeholders. Facilitates internal sharing of investigational findings and risk knowledge. Contributes to metrics related to investigation process and CAPA effectiveness.
  • Participates in site deviation/CAPA management forums related to investigation status updates, metrics and escalation items.  
  • Presents investigations during internal and external audits.Responsible for assigned internal Quality investigations at the Company manufacturing sites   
  • Applies systematic and analytical methods to conduct investigations
  • Documents investigation findings and related actions in alignment with Quality Management System requirements and governing safety regulations
  • Collaborates cross-functionally to ensure robust investigation conclusions, effective communication, and sharing of learnings


Main qualifications
  • B.S. degree in Engineering, Organizational Psychology, Industrial Safety, Forensics or a related scientific discipline
  • Profound xperience in a lab and operations environment (industrial/plant experience preferred)
  • Demonstrated experience in systematic cause analysis methods, including Event & Causal Factor charting, Logic Fault Tree and similar techniques.
  • Strong technical writing skills and ability to synthesize information from multiple SMEs into a coherent, clear and concise narrative. 
  • Ability to interpret technical information and documentation used for operations and production activities. 
  • Experience in management of diverse stakeholders with strong interpersonal/influencing skills. Ability to communicate effectively across organizations. Ability to balance resource demands from multiple internal customers.
  • Experience in performance improvement with basis in Human and Organizational Performance principles.
  • Practical knowledge and application of cGMP, cGLP, EMEA, and OSHA compliance regulations and inspections plus experience interfacing with inspectors, investigators and/or agency personnel.
  • Strong interpersonal skills including the ability to negotiate and resolve challenges with poise, tact and diplomacy.
  • Demonstrated ability to analyze, extrapolate data, synthesize and determine recommendations, including the analysis of complex problems.


Main advantages:
  • You will work in an international, environment
  • This is a temporarly contract with a possibility of extension
  • You will work for an American multinational biotechnology company specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide
  • The site is brand new and will provide you great technology 



About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

My contact at Hays:

My contact person:
Gwladys Céline Beaugeard

Referencenumber:


Make contact:
Email:
Start
ab sofort
Dauer
6 MM
Von
Hays AG
Eingestellt
23.09.2021
Ansprechpartner:
Hays AG
Projekt-ID:
2212143
Vertragsart
Freiberuflich
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