Sr. Compliance Specialist

Location: Caguas, PR
Date Posted: 09-08-2017
Sr. Compliance Specialist
 
 
 Description
 
Seeking a Sr. Compliance Specialist. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry.
 
  Responsibilities
  • Generate report related to the Engineering, Maintenance and Facilities areas.
  • Identify corrective and preventive actions (CAPAs) required for investigations or improvements.
  • Conduct GMP audits to Engineering and Utilities systems.
  • Identify  areas for GMP improvements
  • Discuss investigations with reviewers.
  • Modify procedures as needed.
  • Generate investigation reports for non-conformances related to the Engineering systems, Maintenance, Facilities and Utilities areas such as Calibrations, Water Systems, Maintenance Program, Drafting, Pest control, HVAC, Facilities, etc.
  • Lead Special Response Team (SRT) meetings and submit minutes not later than 3 days after the meeting.
 Skills and Qualifications
  • Good interpersonal skills and problem solving
  • Knowledge with CAPAs
  • Organizational skills
  • Knowledge in reports generations
  • Knowledge  and experience with Root cause analysis tools.
  • Fully bilingual: oral and written
  • Ability to handle multiple projects simultaneously
  • Application of GMPs
  • Leadership and team-building
Requirements
 
  • BS in Engineering field such as Industrial, Chemical, Mechanical or Electrician and 7 or more years of experience in Engineering area, Quality units and in engineering systems such as Maintenance, Calibration, Water System, HVAC, Pest Control, documentation for audits, record keeping, report compilation.
Integrated Technology and Compliance Services is an Equal Opportunity Employer
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