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Specialist QA 34383
InteldotJuncos, Puerto RicoHace 1 día
Descripción del trabajoReview and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports and planned incidents Release of sanitary utility systems. Represent QA on NPI team. Lead investigations and site audits Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities and facilities and environmental programs. Review and approve work orders and EMS / BMS alarms. Approve NC investigations, change control and CAPA records Provide lot disposition and authorize lots for shipment. Doctorate, or Masters + 2 years of directly related experience, or Bachelors + 4 years of directly related experience, or Associates + 8 years of directly related experience, or High school / GED + 10 years of directly related experience. Science or Engineering bachelor Pharmaceutical environment experience Spoken languages : Spanish and English
Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico .
Administrative shift
Job Description :
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Requirements :
- Experienced quality assurance specialist.
- Commissioning and Qualification of Equipment / Systems / Facilities
- Auditing Equipment / Facilities / Utilities of Qualification Protocols and execution
- Revision and approvals of technical documents like URS, Design, Report of technical data.
- Deep knowledge of quality assurance terminology, methods, and tools
- Knowledge on Veeva, CDOCS applications.
Responsibilities :
Education
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Specialist Qa • Juncos, Puerto Rico
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