Team Member - Quality Control(LST)
Core
Ensure compliance with GLP, GDP, and GMP; manage calibration and lifecycle of QC instruments; investigate quality incidents and deviations; support product releases and resolve analytical issues.
Role type
Senior Quality Control Team Member (Laboratory)
Builds
Production of compliant pharmaceutical products and analytical data
Domain
Pharmaceutical manufacturing and quality assurance
Required skills
GLP/GDP/GMP compliance, instrument calibration management, reference standard management, CAPA implementation, audit participation, Lean Daily Management, HPLC/UPLC/GC operation, LIMS/SAP proficiency, SOP adherence, cross-functional collaboration
Preferred skills
Mentorship of analysts, continuous improvement initiatives, change control management
Technologies
SAP, LIMS, Empower, DocHub, iSLATE
Responsibilities
Plan and execute instrument calibration; manage procurement and qualification of reference standards; investigate OOS/OOT results and implement CAPAs; participate in internal and external audits; train and qualify analysts on analytical techniques; ensure laboratory safety and housekeeping.
Seniority
Senior, hands-on IC
