Executive - Quality Control

Overview

Our client is looking for an Executive in the Quality Control to play a key role in for establishing and maintaining the quality control processes for the new facility within a greenfield pharmaceutical setup.

Key Responsibility

• 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 and detailed documentation, including test results, validation reports, and logbooks.
• Prepare, review, and implement standard operating procedures (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 internal and external audits by regulatory authorities.
• Ensure readiness for inspections and address audit observations in a timely manner.
• Work closely with Production, QA, and R&D teams to resolve quality issues.
• Investigate Out of Specification (OOS) and Out of Trend (OOT) results and implement corrective and preventive actions (CAPA).
• Conduct routine environmental monitoring of cleanrooms and controlled areas.
• Trend analysis of environmental monitoring data and implementation of necessary actions to mitigate risks.
• Provide training to junior staff on QC and microbiological techniques.
• Stay updated on advancements in QC and microbiological methodologies and implement them as applicable.

Must Have

• Bachelors/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.