cgmp Quality Validation pharma - MEDVACON TALENT ACQUISITION, LLC

Job Details

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 productchanges.
Identifies and supports continuous improvements
Leads CAPA/NCR/SCAR investigations andreports.

REQUIREMENTS:

Bachelorslevel 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

MEDVACON TALENT ACQUISITION, LLC

04/18/2024

Minnetonka,MN