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Sr Specialist QA (Aseptic Process)

Juncos, PR
Description 
The Sr Specialist QA will review and approve product MP’s. Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Own site quality program procedures. Designee for QA manager on local CCRB. 

Education
Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience.

Requirements
  • Experienced in Aseptic processing manufacturing processes
  • General understanding on Manufacturing Execution Systems (MES) and electronic Batch Records (e-BR).
  • Capable to review and approve complex GMP documents from a Quality standpoint 
  • Ability to conduct GMP quality inspections, walk downs and general oversight to production, utilities and general facility areas with the objective to ensure the required state of Validation.
  • Knowledge on general Validation concepts (e.g. Process Performance Qualifications, Commissioning & Qualification and Validation Life Cycle Management for Equipment and Facilities including Computerized Systems) applied to GMP Pharmaceutical production areas required.
  • Project Management skills.
  • Excellent Technical Writing and general Communication skills in English and Spanish.

Ultimate Solutions Corp is an equal opportunity employer. 

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