Key
Responsibilities
Testing & Analysis
Perform chemical, physical, and instrumental analysis of raw
materials, intermediates, finished products, and packaging components.
Operate analytical instruments such as HPLC, GC, UV-Vis spectrophotometer,
FTIR, dissolution apparatus, and KF titrator.
Conduct water analysis (RO, Purified Water, WFI) as per
pharmacopeial requirements.
Support stability studies by testing stability samples as per
protocol.
Documentation & Compliance
Record all observations and results in relevant formats as per GDP
(Positive Documentation Practices).
Prepare and review test records, specifications, and SOPs.
Maintain laboratory logbooks, instrument usage records, and
calibration records.
Ensure all activities comply with cGMP, WHO GMP, and regulatory
guidelines.




Equipment Handling & Calibration
Ensure proper operation, cleaning, and calibration of laboratory
instruments.
Participate in qualification of laboratory instruments and
equipment.
Audit & Regulatory Support
Assist during internal, customer, and regulatory inspections by
presenting test records and data.
Participate in root cause investigations and CAPA implementation
for OOS, OOT, or deviations.
Coordination
Liaise with QA, Production, and R&D; teams to resolve
quality-related issues.
Coordinate with stability and microbiology teams for testing
requirements.

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