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cgmp Quality Validation pharma

4 months ago

Minnetonka, United States Medvacon Life Sciences LLC Full time
This is a HYBRID in Minnetonka, MN
3 days on-site
6+ months
Local
$75 on W2 max
No c/c

SUMMARY:

Lead validation and quality engineering activities for internally manufactured products, including validation plans, protocols and reports, maintenance of DMR, change control and CAPA/Deviation investigations. This position is the owner of the process validation system and is responsible for developing and maintaining procedures and policies in accordance with regulatory requirements and industry standards.

RESPONSIBILITIES:
  • Develop validation plans, protocols and reports for assembly and packaging processes
  • Develop and manage validation standard operating procedures in compliance with regulatory requirements
  • Develop and maintain validation protocol and report templates
  • Develop test method validation (TMV) protocols and reports for automated and manual inspection methods
  • Provide quality engineering support for semi-manual and automated equipment development
  • Review equipment URS, FAT/SAT against quality requirements
  • Support design transfer of internal manufacturing processes
  • Perform statistical analysis of validation and production data • Supports manufacturing process development & qualification for product changes.
  • Identifies and supports continuous improvements
  • Leads CAPA/NCR/SCAR investigations and reports.

REQUIREMENTS:
  • Bachelors level degree in Engineering (Mechanical or Biomedical) or related Science
  • 5+ years relevant experience within medical device industry or related function
  • Knowledge of GMP, ISO, QSR and other applicable international regulations, standards, Directives and Guidance
  • Good statistical data analysis skills (Minitab)
  • Lead auditor certification preferred
  • Design for Six Sigma and Critical to Quality training and experience a plus
  • Background in manufacturing processes for sterile pharmaceutical products and drug-device combination products related to development and commercial programs a plus