About the role
Key
Responsibilities
1. 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.
2. Documentation & Compliance
- Record all observations and results in relevant formats as per GDP
(Good 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.
3. Equipment Handling & Calibration
- Ensure proper operation, cleaning, and calibration of laboratory
instruments.
- Participate in qualification of laboratory instruments and
equipment.
4. 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.
5. Coordination
- Liaise with QA, Production, and R&D teams to resolve
quality-related issues.
- Coordinate with stability and microbiology teams for testing
requirements.