Responsibilities:
Lead and manage the overall Quality Control function and QC laboratory.
Ensure compliance with cGMP, GLP, ICH, WHO and regulatory requirements.
Oversee testing and release of raw materials, packing materials, in-process and finished products.
Review and approve specifications, analytical reports, SOPs, protocols and COAs.
Handle OOS, OOT, deviations, investigations and CAPA effectively.
Manage stability studies, method validation/transfer and analytical activities.
Ensure readiness and support for regulatory and customer audits/inspections.
Ensure compliance with HPLC, GC, UV, dissolution and other analytical instruments, including calibration and maintenance.
Lead,
train and develop the QC team and ensure optimum utilization of resources.
Drive continuous improvement, laboratory efficiency and quality compliance.
Required Skills:
Robust knowledge of Pharma QC & GMP
Regulatory audit and inspection handling
OOS/OOT, CAPA & deviation management
Analytical method validation/transfer
Stability & laboratory management
Solid leadership and team management skills