Quality Systems Specialist

Job Description

Quality Systems Specialist with experience in the pharmaceutical industry and strong expertise in Quality Systems and SOPs.

In-depth knowledge of GMP, FDA regulations, 21 CFR Part 11, Data Integrity (including Risk Assessment, Data Mapping), and EU regulatory requirements, with the ability to interpret and apply them effectively.

Proficient in computer systems and data collection tools, including Microsoft Office Suite, SAP, and Infinity.

Skilled in data analysis, identifying deviations and inconsistencies, and interpreting sampling and test results.

Experienced in problem solving and root cause analysis methodologies, including 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.

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. Technical and scientific capability to make firm decisions and recommendations. Microsoft Office, SAP, Infinity