Quality Control Pharmacist

Quality Control Pharmacist to join a pharmaceutical manufacturing team in UAE . The ideal candidate will be responsible for ensuring compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory standards while maintaining the highest quality standards for APIs, finished products, and stability samples.

This role is critical in maintaining regulatory compliance, data integrity, laboratory excellence, and continuous improvement within the Quality Management System (QMS).

Job Responsibilities – QC Pharmacist

• Monitor and ensure strict adherence to Good Laboratory Practices (GLP) and Good Documentation Practices (GDP) during routine laboratory operations.
• Ensure laboratory personnel follow approved Standard Operating Procedures (SOPs) and regulatory guidelines.
• Actively participate in laboratory investigations, incidents, and deviation management.
• Review audit trail checklists as per approved procedures to ensure data integrity and compliance.

OOS, OOT & Investigation Management

• Investigate Out of Specification (OOS) results for:
  • Finished products
  • Stability samples
  • Raw materials
  • Packaging materials
• Conduct investigations for Out of Trend (OOT) analytical results as per approved protocols.
• Perform root cause analysis (RCA) and recommend corrective and preventive actions (CAPA).
• Collate and review analytical data for reports, investigations, and regulatory submissions.

Quality Management System (QMS) Activities

• Implement and maintain Quality Assurance systems within QC and R&D functions.
• Handle QMS activities including:
  • Deviations
  • Change controls
  • CAPA
  • Risk assessments
• Contribute to continuous improvement initiatives within the Quality department.
• Prepare and review key performance indicators (KPIs) and quality metrics.

Environmental & Stability Monitoring -Quality Control Pharmacist

• Manage excursions related to:
  • Environmental monitoring
  • Water system monitoring
  • Temperature and relative humidity (RH) in stability chambers, refrigerators, and incubators
• Investigate and document temperature/RH excursions according to regulatory guidelines.
• Ensure compliance with stability protocols and regulatory requirements.

Documentation & Technical Review

• Review and approve technical documents prior to QA submission, including:
  • SOPs
  • Stability protocols and reports
  • User Requirement Specifications (URS)
  • Qualification protocols and reports
  • Out of Calibration (OOC) reports
  • Calibration delay reports
  • Instrument maintenance reports
• Ensure documentation accuracy, completeness, and compliance with GDP requirements.

Instrument Qualification & Calibration

• Ensure all laboratory instruments are:
  • Properly qualified (IQ/OQ/PQ)
  • Calibrated as per schedule
  • Compliant with Computer System Validation (CSV) requirements
• Monitor instrument lifecycle management and maintenance documentation.

Job Qualifications

• Bachelor’s Degree in Pharmaceutical Sciences, Pharmacy, Analytical Chemistry, or related field from an accredited institution.
• Master’s degree in Pharmaceutical Sciences or related field of Quality Control Pharmacist is preferred.
• Minimum 3–5 years of experience in a pharmaceutical manufacturing company within the Quality Control or Quality Assurance function.
• Hands-on experience in:
  • Active Pharmaceutical Ingredients (API)
  • Drug product analysis
  • Analytical development
  • Stability studies
  • GMP-compliant laboratory operations

Quality Control in Pharmacy

• Strong knowledge of:
  • GLP (Good Laboratory Practices)
  • GMP (Good Manufacturing Practices)
  • GDP (Good Documentation Practices)
  • Quality Assurance principles
• Excellent documentation and technical writing skills.
• Strong analytical and problem-solving abilities.
• Proficiency in:
  • Microsoft Office (Word, Excel, PowerPoint)
  • Laboratory software systems
  • Quality Management Systems (QMS)
• Ability to interpret analytical data and apply scientific principles effectively.

Candidates with the following knowledge will have a competitive advantage:

• Knowledge of Microbiology laboratory activities
• Understanding of pharmaceutical manufacturing processes:
  • Sterile dosage forms
  • Non-sterile dosage forms
• Experience using statistical software for data analysis
• Exposure to regulatory audits and compliance inspections.

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