Title: Analytical Chemist - Reports to: Head of Research & Development
JOB PURPOSE:
To undertake analytical testing to develop new formulations and to establish stability of pharmaceutical finished products to support R & D department.
CORE RESPONSIBILITIES:
1. To perform analytical testing using typical pharmaceutical analytical instruments HPLC, UV spectrophotometer, FT-IR and Karl Fischer etc...
2. To perform simple lab techniques to test density, viscosity, gravimetric testing etc...
3. To qualify analytical instruments such as HPLC, UV, stability chambers.
4. To write up product specifications as per ICH guidelines
5. To prepare stability protocols as per ICH guidelines
6. To develop test methods using HPLC for assay and related substances
7. To validate test methods for assay & related substances
8. To write up validation work results in reports.
9. To support R & D formulation team for additional testing requirements.
10. To undertake maintenance of relevant analytical instruments.
11. To ensure the required initial and continuing training relating to work performed.
12. To organise storage of raw material samples (APIs & excipients, finished products) & documentations such as Certificate of Analysis& MSDS and Calibration Certificates.
13. To write up quality documentation...