Manager - QC
Dishman Carbogen Amcis Ltd, Indiana, PA, United States
Analytical Method Validation Expertise
Strong understanding of analytical method validation principles and regulatory guidelines (ICH Q2(R1), USP, etc.)
Analytical Techniques Proficiency
HPLC (High-Performance Liquid Chromatography)
GC (Gas Chromatography)
FT-IR
UV-Visible Spectroscopy
ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
GC-MS (Gas Chromatography-Mass Spectrometry)
Regulatory Compliance
Experience in preparing and reviewing validation protocols and reports
Familiarity with global regulatory requirements (FDA, EDQM, ANVISA, PDMA, etc.)
Exposure to regulatory audits and inspections
Documentation & Quality Systems
Good documentation practices (GDP)
Knowledge of laboratory quality systems and data integrity requirements
Experience with LIMS or other lab data management systems
Problem Solving & Troubleshooting
Ability to troubleshoot analytical methods and instrumentation issues
Root cause analysis and CAPA implementation
Project & Team Management
Experience in handling method validation projects independently
Ability to manage and mentor a team of at least 15 members
Communication & Collaboration
Effective communication with cross-functional teams (R&D, QA, RA)
Ability to present findings and defend validation data during audits
Additional Preferred Skills
Exposure to method development and transfer activities
Experience with other regulatory bodies (e.g., TGA, MHRA, WHO)
#J-18808-Ljbffr
Strong understanding of analytical method validation principles and regulatory guidelines (ICH Q2(R1), USP, etc.)
Analytical Techniques Proficiency
HPLC (High-Performance Liquid Chromatography)
GC (Gas Chromatography)
FT-IR
UV-Visible Spectroscopy
ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
GC-MS (Gas Chromatography-Mass Spectrometry)
Regulatory Compliance
Experience in preparing and reviewing validation protocols and reports
Familiarity with global regulatory requirements (FDA, EDQM, ANVISA, PDMA, etc.)
Exposure to regulatory audits and inspections
Documentation & Quality Systems
Good documentation practices (GDP)
Knowledge of laboratory quality systems and data integrity requirements
Experience with LIMS or other lab data management systems
Problem Solving & Troubleshooting
Ability to troubleshoot analytical methods and instrumentation issues
Root cause analysis and CAPA implementation
Project & Team Management
Experience in handling method validation projects independently
Ability to manage and mentor a team of at least 15 members
Communication & Collaboration
Effective communication with cross-functional teams (R&D, QA, RA)
Ability to present findings and defend validation data during audits
Additional Preferred Skills
Exposure to method development and transfer activities
Experience with other regulatory bodies (e.g., TGA, MHRA, WHO)
#J-18808-Ljbffr