Overview
Our client is looking for an Executive in Quality Control to play a key role in establishing and maintaining quality control processes for a new facility within a greenfield pharmaceutical setup.
Key Responsibilities
- Perform routine and non-routine microbiological, chemical, and environmental testing of raw materials, intermediates, and finished products.
- Conduct sterility testing, microbial limit tests, endotoxin testing, and water analysis.
- Manage stability studies as per approved protocols.
- Ensure all QC activities comply with cGMP, GLP, and regulatory standards, including local UAE Ministry of Health guidelines.
- Maintain accurate documentation, including test results, validation reports, and logbooks.
- Prepare, review, and implement SOPs relevant to QC and microbiology.
- Ensure calibration of QC instruments such as HPLC, GC, UV-Vis spectrophotometer, FTIR, and microbiology-specific instruments like autoclaves, incubators, and particle counters.
- Perform periodic validation and qualification of laboratory instruments.
- Support audits by regulatory authorities and ensure readiness for inspections.
- Work closely with Production, QA, and R&D teams to resolve quality issues.
- Investigate OOS and OOT results and implement CAPA.
- Conduct routine environmental monitoring of cleanrooms and controlled areas.
- Analyze environmental monitoring data and implement necessary risk mitigation actions.
- Provide training to junior staff on QC and microbiological techniques.
- Stay updated on advancements in QC and microbiological methodologies and apply them as applicable.
Qualifications
- Bachelor's or master's degree in Microbiology, Pharmacy, Chemistry, or a related field.
- 5-7 years of experience in Quality Control and Microbiology within the pharmaceutical industry, preferably in a greenfield project or similar setup.
Location: Dubai, United Arab Emirates