Quality Systems Specialist
Quality Systems Specialist
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6years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Knowledge in Quality Systems and SOP.
- Strong knowledge of relevant GMP FDA 21 CFR Part 11 and Data Integrity Regulations (Risk Assessment Data Mapping etc) EU regulations and the ability to interpret and apply them for intended use.
- Proficient knowledge of computer systems (Microsoft Office etc.) with data collection software (database) and applications like Infinity and SAP.
- Solid ability for analyzing data detecting deviations inconsistencies and interpret sampling test results.
- Proficient knowledge of problem solving and root cause analysis methodologies (i.e. Kepner Tregoe).
Requirements
- Bachelor s degree in science (Chemical Engineering Biology Pharmacy or Microbiology)
- Six (6) years of experience in project management investigations or relevant roles and responsibilities
in the pharmaceutical industry. - Fully bilingual (Spanish/English) communication skills both written and verbal.
- Self-motivated creative and teamwork oriented.
- Technical and scientific capability to make firm decisions and recommendations.
- Sense of urgency and analytical thinking.
- Microsoft Office SAP Infinity
Employment Type
Full Time
