Specialist QA
Specialist QA
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Specialist QA with expertise in Quality Systems such as Deviations (Non-conformities CAPA and Change Control). Hands on experience in electronic systems for instance: Documentation platforms (CDOCS) Maximo Trackwise LIMS electronic batch record (MES) and SAP. Experience with Validation of GxP applications Validation Master Plan Installation Qualification (IQ) Risk Assessment/GxP assessment Operational Qualification (OQ) and Performance Qualification (PQ) Protocols Test Scripts and Completion/Summary Reports approvals as per the compliance requirements. Validated experience as Quality Contact for sophisticated projects involving new drug substances /products with experience in commissioning and qualifications. Enhanced skills in leading influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
Qualifications :
- Doctorate or Masters Degree 2 years of directly related experience or
Bachelors Degree 4 years of directly related experience or
Associates 8 years of directly related experience - Computer Literacy
- Bilingual (Spanish/English)
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
