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.