Job Summary: Responsible for performing quality control testing of peptide products, including in-process (IPQC), finished products, stability studies, and analytical method validation, ensuring compliance with regulatory and quality standards.
Key Responsibilities:
- Perform IPQC (In-Process Quality Control) analysis for peptide manufacturing batches, conduct testing of finished products as per approved specifications and test methods, and carry out stability studies including sample analysis, documentation, and reporting.
- Execute analytical method validation and method transfer activities as per ICH guidelines.
- Operate and maintain analytical instruments such as HPLC, UPLC, GC, LC-MS, KF, UV spectroscopy, etc.
- Prepare and review analytical reports, SOPs, STPs, and protocols.
- Ensure data integrity and compliance with GMP/GLP requirements.
- Perform calibration and routine maintenance of laboratory instruments.
- Investigate OOS (Out of Specification), OOT (Out of Trend), and deviations.
- Maintain proper documentation in line with regulatory requirements (FDA, EMA, ICH).
- Support audit readiness and participate in internal/external audits.
- Coordinate with production and QA teams for smooth workflow.
Education:
- Master's degree in chemistry or Life Sciences.
Experience:
- 03-06 years in Experience in peptide QC or pharmaceutical industry preferred.
Skills and Competencies:
- Strong knowledge of analytical techniques (HPLC/UPLC/LC-MS)
- Understanding of GMP, GLP, ICH guidelines
- Good documentation and data handling skills
- Problem-solving and investigation skills
- Attention to detail and quality-oriented mindset
- Team collaboration and communication skills
