Specialist - Quality Control

Overview

The Quality Control Specialist based at Julphar headquarters in Ras Al Khaimah is responsible for strictly following and upholding current Good Manufacturing Practices (cGMP) to ensure the quality and compliance of pharmaceutical products. This role involves conducting chemical and physical testing of finished products, raw materials, and stability samples, as well as validating manufacturing processes. The Specialist operates and manages QC instrumentation, ensures compliance with GLP, GMP, and safety norms, while maintaining sterile and hygienic laboratory conditions.

Key Duties

• Perform chemical and physical analyses on raw materials, finished products, and stability samples, including process validations.
• Operate diverse QC equipment in compliance with procedures and safety standards.
• Maintain data integrity by accurately recording work data and entering results into SAP.
• Provide assistance to supervisors and train newly recruited staff members on protocols and operations.
• Create and validate analytical methods for HPLC and GC testing based on approved pharmacopeia standards before analysis starts.
• Review and process all HPLC and GC analytical data, including audit trails for instrumentation.
• Investigate laboratory incidents such as out-of-specification (OOS) or out-of-trend (OOT) results, performing root cause analysis and initiating corrective and preventive actions.
• Support and participate in internal and external audits, addressing observations promptly.
• Prepare and approve validation reports related to methods, transfers, process, and stability testing.
• Handle Quality Management System documentation including deviations, CAPAs, change controls, and notifications using the Amplelogic system.
• Ensure adherence to GLP, GMP, safety protocols, and maintain cleanliness within the laboratory environment.
• Coordinate with cross-functional teams and manage changing priorities effectively.
• Perform any additional tasks delegated by the Head of Department or their designee.

Core Competencies

• Strong accountability and ownership with meticulous attention to detail.
• Excellent process compliance and implementation skills.
• Effective communication, interpersonal, and problem-solving capabilities.
• Business acumen combined with commitment to regulatory compliance.
• Adaptability to evolving work conditions and priorities.
• Highly organized, self-driven to learn and apply new knowledge in the work environment.
• Ability to collaborate across different departments internally and externally.

Qualifications and Experience

• Bachelor’s degree in pharmacy or science discipline.
• A minimum of 3 to 6 years of relevant experience in quality control within pharmaceutical or related sectors.
• Proficiency in using computer software relevant to quality control operations.
• Demonstrated expertise in applying cGMP guidelines and conducting chemical and physical testing.
• Experience operating a variety of QC instruments while ensuring adherence to GLP, GMP, and safety standards.