Project Validation Specialist Iii

Há 4 dias


Curitiba, Paraná, Brasil Pharma-Bio Serv Inc. Tempo inteiro

Job Description
Pharma-Bio Serv
, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio-engineering companies within the regulated industry for over 30 years. Since our inception, our services have resulted in project experience level and personnel resource base ranking among the highest worldwide.
Currently, one of our clients in the
West Region
sector is looking to hire a
Project Validation Specialist
.
Requirements:
Bachelor's degree in Engineering or Science is required, with at least 7 years of direct experience.
Participate in the discovery and compilation of required documentation to be evaluated.
Support assessment of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports/memos) and manufacturing documentation update through site change orders system.



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