Job Description


The candidate responsibilities include mainly

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.
  • Organize and maintain supplies for testing.
  • Oversee all testing, including special project / protocol testing in a timely and appropriate manner.
  • Perform laboratory and manufacturing audits as required. Audit and update, as required, lab SOPs
  • Investigate deviations and write exception documents.
  • Participate in functions improvement teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.
  • Ensure equipment maintenance and calibration, and internal audits are performed on schedule.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data.
  • Work closely with the Validation Lead and Business Analyst to ensure test scripts are ready for OQ and PQ.
  • Other duties include: run validation test scripts as assigned, assist with preparing and updating validation documentation including specifications, defects, etc.
  • Minimum Diploma or relevant work experience in information systems, engineering or science..
  • Highly skilled in Computerized System testing and validation in the healthcare industry.
  • Knowledge of GxP regulations (e.g. 21 CFR Part 11,etc.) Ability to multi-task. Must have strong analytical problem solving skills. Excellent communication including written, verbal, and listening skills. Self-motivated, detail oriented, takes initiative and ability to work without close supervision.