Specialist QA

hace 4 semanas


Juncos, Puerto Rico QRC Group, Inc A tiempo completo
Job Description

Specialist QA with expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control). Experience in Facilities, Equipment and Utilities Validations. 

Skills:

  • Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
  • Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
  • Validated experience as Quality Contact for sophisticated projects involving new drug substances /products with experience in commissioning, facility, utility, and equipment qualifications.
  • Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.

Qualifications

  • Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience years of directly related experience (Sciences or Engineering)
  • Bilingual (Spanish/English)(Write/Speak)
  • Computer Literacy



Additional Information

All your information will be kept confidential according to EEO guidelines.


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