Requirements
Bachelor's degree in pharmacy or science with a Major in Chemistry is mandatory. Minimum 10 years of relevant experience in pharmaceutical Quality Control, preferably in Raw Materials analysis, with previous experience in a Senior/Lead QC Raw Materials position highly preferred. Strong practical knowledge of raw material testing, pharmaceutical analytical chemistry, analytical instruments (HPLC, GC, UV-Vis, IR), GMP, GLP, pharmacopoeial requirements, specifications, data integrity, OOS/OOT investigations, CAPA, change control, root cause analysis, and analytical method validation/verification/transfer. Strong leadership, team-management, analytical, problem-solving, and communication skills are essential. Good command of English and proficiency in Microsoft Office applications are required.
Description
QC Raw Materials LeadCompany: PHARCO CorporationJob Title: QC Raw Materials LeadDepartment: Quality ControlLocation: Alexandria, EgyptReporting To: QC ManagerJob PurposeThe QC Raw Materials Lead is responsible for leading and supervising all Quality Control activities related to the sampling, testing, analysis, and release of raw materials and packaging materials. The role ensures that all activities are performed accurately, efficiently, and in compliance with GMP, GLP, pharmacopoeial requirements, approved specifications, and applicable regulatory standards.The position provides technical leadership to the Raw Materials QC team, ensures timely release of materials, supports investigations, and maintains a high level of laboratory compliance and inspection readiness.Key Responsibilities1. Raw Materials QC Operations• Lead and supervise daily QC activities related to raw materials and packaging materials.• Ensure timely sampling and testing of incoming raw materials according to approved procedures and specifications.• Review and approve analytical results and laboratory documentation.• Ensure that raw materials are tested using approved analytical methods and current specifications.• Monitor the status of materials under testing and ensure timely release or rejection.• Coordinate with Warehouse, QA, Procurement, and other relevant departments to ensure smooth material flow.• Monitor laboratory workload and effectively distribute tasks among QC Raw Materials analysts.2. Analytical Testing & Technical Support• Ensure proper execution of chemical and physical testing of raw materials according to applicable pharmacopoeial and internal requirements.• Provide technical guidance to analysts regarding analytical procedures and troubleshooting.• Ensure proper operation, calibration, and maintenance of laboratory instruments used for raw material testing.• Support analytical method verification, validation, transfer, and implementation when required.• Review analytical calculations, chromatograms, worksheets, and related laboratory records.3. GMP & Compliance• Ensure all raw material testing activities comply with GMP, GLP, SOPs, pharmacopoeial standards, and approved specifications.• Ensure complete and accurate documentation in accordance with data integrity requirements.• Maintain the Raw Materials QC laboratory in a state of continuous inspection readiness.• Ensure proper implementation and adherence to approved SOPs and laboratory procedures.• Participate in internal, customer, and regulatory audits and inspections.4. OOS, OOT & Laboratory Investigations• Lead and support investigations related to OOS, OOT, deviations, analytical errors, and atypical results.• Conduct appropriate root cause analysis and provide scientifically justified conclusions.• Define and follow up on corrective and preventive actions (CAPA).• Provide technical input during investigations involving suppliers or raw material quality issues.• Identify recurring analytical or material-related issues and recommend preventive actions.5. Supplier & Material Quality Support• Support QA activities related to raw material supplier qualification and performance monitoring.• Participate in investigations related to supplier complaints and material quality issues.• Review and assess analytical results against approved specifications.• Support evaluation and implementation of new raw material specifications and analytical methods.• Coordinate with QA regarding material status, deviations, and quality-related concerns.6. Team Leadership & Development• Lead, supervise, and develop QC Raw Materials analysts.• Assign daily tasks and monitor team performance and workload.• Provide technical coaching and on-the-job training to team members.• Identify competency and training gaps and support the implementation of appropriate training plans.• Evaluate team performance and provide regular feedback.• Promote a strong culture of GMP compliance, teamwork, and continuous improvement.7. Documentation & Data Review• Review laboratory notebooks, worksheets, analytical results, calculations, chromatograms, and relevant records.• Ensure all laboratory documentation is complete, accurate, traceable, and properly archived.• Prepare and review periodic reports related to raw material testing and laboratory performance.• Ensure proper handling of laboratory data in accordance with data integrity principles.8. Continuous Improvement• Identify opportunities to improve the efficiency and effectiveness of raw material testing activities.• Participate in quality improvement and laboratory optimization projects.• Support implementation of new analytical technologies and procedures.• Monitor testing turnaround time and identify opportunities to reduce delays without compromising quality or compliance.• Contribute to risk assessment and process improvement initiatives within QC.Job Requirements• Bachelor's degree in pharmacy or science with a Major in Chemistry.• Chemistry major is mandatory for Chemist positions; a Minor in Chemistry is not considered sufficient.• Minimum 10 years of relevant experience in pharmaceutical Quality Control, preferably in Raw Materials analysis.• Previous experience in a Senior / Lead QC Raw Materials position is highly preferred.• Strong practical knowledge of raw material testing and pharmaceutical analytical chemistry.• Hands-on experience with analytical instruments such as HPLC, GC, UV-Vis, IR, and other relevant laboratory instruments.• Good knowledge of GMP, GLP, pharmacopoeial requirements, specifications, and data integrity principles.• Strong experience in OOS/OOT investigations, deviations, CAPA, change control, and root cause analysis.• Good knowledge of analytical method validation/verification and transfer.• Strong leadership and team-management skills.• Excellent analytical and problem-solving abilities.• Good communication and coordination skills.• Good command of English language, particularly technical and pharmaceutical terminology.• Proficiency in Microsoft Office applications.