Sr. Specialist

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Job Purpose

To oversee and coordinate Quality Control laboratory operations, ensuring accurate, timely, and compliant testing of finished products and stability samples in accordance with approved specifications, analytical methods, GMP, GLP, pharmacopoeial standards, and regulatory requirements. The role is responsible for analytical data review, laboratory compliance, investigation management, analyst qualification, stability management, and continuous improvement of QC processes.

• Key Responsibilities
• QC Laboratory Operations & Analytical Testing
• Supervise and coordinate chemical and physical analysis of finished products and stability samples, ensuring timely execution and compliance with approved testing procedures.
• Allocate testing activities to analysts and monitor workload, priorities, and timely completion of analysis.
• Ensure finished products comply with approved specifications, pharmacopoeial standards, and applicable regulatory requirements.
• Oversee the operation, maintenance, calibration, and performance monitoring of QC laboratory instruments, including HPLC, GC, UV-Visible Spectrophotometer, FTIR, AAS, Karl Fischer Titrator, Dissolution Tester, Disintegration Tester, pH Meter, Conductivity Meter, TOC Analyzer, Melting Point Apparatus, Refractometer, and Polarimeter.
• Develop and implement analytical methods in accordance with approved specifications, STMs, and applicable pharmacopoeial requirements.
• Support troubleshooting of analytical instruments, testing procedures, and laboratory operational issues.
• Analytical Data Review & Laboratory Compliance
• Review and approve HPLC and GC analytical data generated by analysts, ensuring accuracy, completeness, and compliance with approved procedures.
• Review analytical records, instrument audit trails, raw data, calculations, and laboratory documentation to ensure data integrity and traceability.
• Ensure adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), data integrity requirements, and applicable safety procedures.
• Ensure laboratory activities are performed in accordance with approved SOPs, specifications, analytical methods, and regulatory guidelines.
• Review and approve laboratory documentation, including analytical records, protocols, reports, and relevant technical documents.
• Maintain appropriate laboratory hygiene, housekeeping, and safety standards.
• Investigations, Deviations & CAPA
• Lead or participate in investigations related to laboratory incidents, Out-of-Specification (OOS), Out-of-Trend (OOT) results, deviations, and other quality events.
• Conduct scientific assessments, root cause analysis, and risk assessments to identify the underlying causes of laboratory issues.
• Define, implement, and monitor appropriate Corrective and Preventive Actions (CAPA) to prevent recurrence.
• Ensure investigations and associated documentation are completed accurately and within established timelines.
• Support continuous improvement initiatives to enhance laboratory efficiency, compliance, and quality performance.
• Stability Management & Validation
• Coordinate and manage stability studies, including sample management, testing schedules, analytical execution, and documentation.
• Prepare, review, and evaluate stability protocols, reports, and trend analyses.
• Review and approve protocols and reports related to analytical method validation, method transfer, process validation, and stability studies, applicable.
• Ensure stability testing is performed in accordance with approved protocols, applicable regulatory requirements, and established timelines.
• Identify and assess stability trends and potential quality concerns, escalating significant findings to the appropriate stakeholders.
• Training & People Development
• Train and qualify QC analysts on applicable SOPs, specifications, analytical methods, testing procedures, and laboratory practices.
• Support the onboarding and development of newly appointed QC personnel.
• Assess analyst competency and ensure personnel are qualifi