Quality Control Officer API & Excipients
Key Responsibilities:
- Conduct routine analysis of raw materials, intermediates, and finished products using techniques like HPLC, GC, UV, IR, and titration.
- Ensure compliance with cGMP, ICH, and regulatory standards during testing and documentation.
- Prepare and review Certificates of Analysis (CoA), standard operating procedures (SOPs), and test protocols.
- Maintain laboratory instruments through regular calibration and validation.
- Support vendor qualification by testing excipient samples and preparing evaluation reports.
- Participate in investigations of out-of-specification (OOS) results and deviations.
Qualifications:
- Bachelor's or Master's in Chemistry, Pharmaceutical Sciences, or related field.
- 15 years of experience in pharmaceutical QC, preferably in API or excipient testing.
