CAPA Manager

Published: June 3, 2020
Location
West Region, Puerto Rico
Job Type
Job Code
23529
Years of Experience
5
Salary
Commensurate with Candidate Experience
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

Responsibilities:

  • 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.

Requirements

  • 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.
Apply
Drop files here browse files ...
Required

Related Jobs

Quality Manager   Metro Area, Puerto Rico, Puerto Rico
January 17, 2020
Are you sure you want to delete this file?
/