Our client, a growing specialty pharmaceutical company with infrastructures for R&D, manufacturing, distribution, and marketing. Their vast portfolio are distributed to retail pharmacies, hospitals and clinics. Their products are also exported to several countries.
As Senior QC Associate you will reports to Quality Control Manager. Your main responsibilities are:
- Performing tests for certification of analysis of raw material, finished products and stability samples
- Documenting and reporting results in accordance with GMP and GLP
- Participate in method validation protocol and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelines
- Participate in method development and method validation/verification for API and finished products
- Conducting investigation of unexpected issues in developmental and regular products as directed and provides solutions to resolve the findings
- Bachelor in Chemistry
- 3+ years of QC experience in the Pharmaceutical industry
- Strong knowledge of GMP, GLP, analytical techniques and method validation.
- Sound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.
- Knowledge of OPENLAB (EZChrom)
- Very good knowledge of ICH and FDA requirements
- Excellent organizational skills to meet frequent changes in immediate priorities, problem solving skills, and understanding of various computer software programs required
- Excellent oral and written communication skills in English and French