Company Description
Validation & Engineering Group, Inc. is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, among other services in Puerto Rico and USA.
Job Description
Support Quality Assurance program:
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Non Conformances
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Review and approve product MPs.
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Approve validation protocols and reports for manufacturing processes.
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Approve Environmental Characterization reports.
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Lead investigations.
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Review Risk Assessments.
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Support Automation activities.
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Support facilities and environmental programs.
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Approve investigations and CAPA records.
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Approve change controls.
Qualifications
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Bachelor’s degree Sciences o Engineering and 3 to 5 years of directly related experience.
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Project management skills.
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Strong organizational skills.
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Strong knowledge in area of expertise.
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Collaborate and coordinate with higher level outside resources.
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Strong knowledge of and experience with processes involved in manufacturing and distribution.
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Validation and process development.
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Demonstrate ability to interact with regulatory agencies.
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Strong word processing, presentation, database and spreadsheet application skills.
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Strong communication (both written and oral), facilitation and presentation skills.
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Ability to evaluate compliance issues.
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Available to work non-standard shifts requested.
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Fully Bilingual (Spanish & English).
Additional Information
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.