Published: June 3, 2020
- Implement NC/CAPA Program governance and sustain.
- Ensure compliance with specifications, SOPs, GMPs, ISO standards and any other applicable regulatory requirements.
- Recommend & execute NC/CAPA process improvement projects.
- Ensure NC/CAPA key performance indicators compliance. Monitor other investigations related to complaint.
- Serve as resident expert in NC/CAPA regulatory/compliance.
- Monitor and trend information related to root cause analysis, corrections, corrective and preventive actions, and tracking of timelines.
- Monitor effectivity of the CAPA System.
- Coordinate NC/CAPA weekly governance meetings and act as advisor on adequate root cause analysis, CAPA plan and effectiveness checks.
- Assist/interface with NC/CAPA owners on investigations and action plans.
- Conduct training on root cause analysis and problem-solving techniques.
- Bachelor’s degree required, preferably with an education background in science, engineering, manufacturing.
- Minimum 5 years of experience technical writing and/or procedure development, in medical device, pharmaceutical, or another FDA regulated environment
- Knowledge of Pharmaceutical and Medical Device regulations, statistical sampling and analysis.
- Strong knowledge of the English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
- Seven to ten years minimum work experience in regulated industry.
- 5 years minimum managing CAPA Quality System.
- Exposition/experience managing Regulatory agencies external audits desired.
- Familiarity with requirements for regulatory submissions and guidelines for pharmaceuticals, biologics, and medical devices.
- Experience in reviewing and writing regulatory submission documents for global regulatory filings to include 510(k), IMPD, INDs, MAAs NDAs, and BLAs.
- Knowledgeable of applicable FDA regulations and ISO Standards: 21 CFR 211/ 820 ISO 13485 and ISO 14971 and EU Medical Device Directive.
- Knowledge in laboratory, critical systems and manufacturing quality operation areas.
- Knowledge of problem-solving techniques, Process & Risk Management.
- Strong Leadership and Analytical Skills.
- Experience in managing FDA Audits.
- Requires advanced critical thinking and technical writing skills
- Good organizational, communication, and interpersonal skills are necessary, understanding of Quality process.
- Communicating effectively in writing as appropriate to the audience.
- Knowledge on Word, Visio, Excel, and other electronic systems to complete tasks.
- Strong prioritization and multitasking skills.