Cgmp Quality Validation Pharma

Job summary
Lead validation and quality engineering activities for internally manufactured productsDevelop and maintain procedures and policies in accordance with regulatory requirements and industry standardsSupport design transfer of internal manufacturing processes
Job seniority: mid-to-senior level
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 manufacturing process development & qualification for product changes• Identify and support continuous improvements• Lead 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
Key Skills Needed
• Good statistical data analysis skills (Minitab)• Lead auditor certification• Design for Six Sigma and Critical to Quality training and experience