The Quality Control Manager is responsible for managing and approving all
Quality Control activities
related to
Chemical, Instrumentation, and Microbiology testing
, ensuring compliance with regulatory and quality standards.
Key Responsibilities Chemical Analysis
Oversee testing of
raw materials, in-process samples, and finished products
Review and approve
analysis reports, COAs, STPs, and test results
Ensure compliance with pharmacopeia and internal specifications
Instrumentation Control
Manage analytical instruments such as
HPLC, GC, UV, FTIR, AAS, Karl Fischer, Dissolution, pH, TOC
etc.
Ensure
calibration, validation, IQ/OQ/PQ, and maintenance
of instruments
Review chromatograms, system suitability, and analytical data integrity
Microbiology Control
Supervise
microbiological testing
, environmental monitoring, water testing, and hygiene controls
Review and approve microbiology reports and trends
Ensure contamination control and compliance with microbiological standards
Compliance & Documentation
Ensure adherence to
GMP, GLP, ISO, WHO-GMP
requirements
Maintain
GDP-compliant documentation
Handle
OOS, OOT, deviations, and CAPA
related to QC
Audit & Team Management
Support regulatory, customer, and internal audits
Train and supervise QC analysts and microbiologists
Coordinate with QA, Production, and R&D teams