04 Aug
|
TalentXplore
|
Una
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 (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.
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.
📌 QC Executive (Una)
🏢 TalentXplore
📍 Una