Quality Engineer/ Scientist - CQE CERTIFICATION REQUIRED
Location: Carolina, pr
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:
- Non Conformances
- Review and approve product MPs.
- Approve validation protocols and reports for manufacturing processes.
- Approve Environmental Characterization reports.
- Lead investigations.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Approve investigations and CAPA records.
- Approve change controls.
Qualifications
- Bachelor’s degree Sciences o Engineering and 3 to 5 years of directly related experience.
- Project management skills.
- Strong organizational skills.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution.
- Validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Ability to evaluate compliance issues.
- Available to work non-standard shifts requested.
- Fully Bilingual (Spanish & English).
Additional Information
Validation and Engineering Group, Inc is an Equal Employment Opportunity employer.
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