Job Description

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 DESCRIPTION

Senior Specialist – Quality Control (QC)

1. 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.

2. Key Responsibilities

A. 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.

B. 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.

C. 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.

D. 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, as 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.

E. 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 qualified to perform assigned analytical activities.
• Provide technical guidance and support to analysts in resolving laboratory issues and improving analytical performance.
• Promote a culture of accountability, collaboration, compliance, and continuous learning within the QC laboratory.

F. Documentation, SAP & Resource Management

• Review and verify analytical data and laboratory records entered by analysts into SAP.
• Ensure timely and accurate locking of analytical results in SAP, in accordance with established procedures.
• Create and manage notifications and reservations for chemicals, reagents, consumables, and other laboratory requirements.
• Monitor availability of laboratory resources and coordinate replenishment to ensure uninterrupted testing operations.
• Prepare, review, and update SOPs, Quality Risk Management (QRM) documents, and other applicable QC documentation.
• Ensure accurate documentation, record retention, and traceability of all QC laboratory activities.

G. Audits & Regulatory Readiness

• Support internal and external audits, regulatory inspections, and quality assessments related to QC laboratory operations.
• Ensure laboratory documentation, analytical records, and operational practices are maintained in a state of inspection readiness.
• Address audit observations and coordinate implementation of corrective actions within agreed timelines.
• Provide technical support and relevant documentation during audits and inspections.

H. HSE & Environmental Management

• Ensure adherence to Environmental Management System (EMS), Health, Safety, and Environment (HSE) requirements within QC laboratory operations.
• Monitor compliance with laboratory safety procedures, environmental requirements, and applicable standards.
• Conduct or support incident investigations, root cause analysis, and implementation of corrective and preventive actions.
• Promote environmental performance improvement initiatives and a strong HSE culture through monitoring, training, and guidance.
• Ensure personnel follow appropriate safety practices while handling chemicals, reagents, equipment, and laboratory waste.

I. Performance Management & Stakeholder Collaboration

• Monitor and manage departmental KPIs related to analytical testing, laboratory compliance, investigation closure, stability activities, and operational efficiency.
• Coordinate effectively with QC supervisors, HODs, Quality Assurance, Production, Engineering, and other relevant stakeholders.
• Support the QC Supervisor, HOD, or designated authority in assigned operational and strategic initiatives.
• Demonstrate strong ownership, accountability, and result orientation while managing multiple priorities and changing business requirements.

3. Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a relevant scientific discipline.
• Relevant experience in Quality Control within the pharmaceutical manufacturing industry.
• Experience in pharmaceutical analytical testing, laboratory operations, and analytical data review.
• Practical experience with chromatographic techniques, particularly HPLC and GC, and other relevant QC analytical instruments.
• Experience in stability management, analytical method validation, method transfer, and laboratory investigations.
• Demonstrated experience in supervising, coordinating, or providing technical guidance to QC analysts.
• Experience in GMP-regulated environments and preparation/review of QC documentation.

4. Technical Competencies

• Strong knowledge of pharmaceutical GMP, GLP, GDP, data integrity, and applicable pharmacopoeial standards.
• Proficiency in analytical testing techniques and laboratory instrumentation.
• Strong understanding of OOS, OOT, deviation management, CAPA, root cause analysis, and Quality Risk Management.
• Knowledge of analytical method validation, method transfer, stability studies, and process validation.
• Familiarity with SAP and laboratory documentation systems.
• Knowledge of audit requirements, regulatory compliance, and laboratory safety standards.
• Ability to interpret analytical data and make scientifically sound decisions.

5. Behavioral & Leadership Competencies

• Strong analytical thinking and scientific problem-solving capabilities.
• Excellent planning, coordination, and prioritization skills.
• Effective communication and stakeholder management skills.
• Strong people management, coaching, and training capabilities.
• High sense of accountability, ownership, and result orientation.
• Attention to detail, accuracy, and commitment to data integrity.
• Ability to adapt to changing priorities and manage multiple tasks effectively.
• Strong written and verbal communication skills in English.
• Business awareness, professional integrity, and commitment to regulatory compliance.
• Demonstrated ability to conduct risk assessments and support continuous improvement initiatives.

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar