
Senior Analytical Scientist
3 days ago
Quality Assurance Specialist
This is a challenging role for an analytical chemist who wishes to apply their skills in a laboratory-based setting. The ideal candidate will have a strong background in analytical techniques and a passion for quality assurance.
- Main Responsibilities:
- We are looking for a Quality Assurance Specialist to join our team. In this role, you will be responsible for the sampling and analysis of raw materials, intermediates, and finished products. You will also conduct routine and non-routine chemical and physical tests to ensure that our products meet the required quality standards.
- You will analyze products using techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Vis spectroscopy, FTIR, and other analytical instruments.
- Sampling and Analysis:
- Perform sampling of raw materials, intermediates, and finished Active Pharmaceutical Ingredients (APIs) according to standard procedures.
- Conduct routine and non-routine chemical and physical tests to ensure quality standards are met.
Documentation:
- Achieve accurate documentation of all analytical results and observations in laboratory notebooks or electronic systems.
- Prepare and review certificates of analysis (CoA) for finished products and intermediates.
Compliance and Standards:
- Ensure adherence to established quality standards as per pharmacopeias (USP, BP, IP, EP, etc.) and regulatory guidelines.
- Implement effective solutions for OOS and deviations.
Instrument Calibration and Maintenance:
- Regularly calibrate, qualify, and perform preventive maintenance on laboratory equipment.
Stability Studies:
- Manage stability studies for APIs to determine shelf life and storage conditions.
Method Development and Validation:
- Collaborate in the development, optimization, and validation of analytical methods for new APIs.
Training and Knowledge Sharing:
- Train junior staff on QC procedures, analytical techniques, and safety protocols.
Key Performance Indicators (KPIs):
- Accuracy and reliability of analytical results.
- Timely completion of testing and reporting.
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