QA Operations Lead – Pharmacist

Position PurposeThe QA Operations Lead – Pharmacist ensures the implementation of the site quality strategy through proactive quality oversight of production operations and related activities, including process validation, cleaning validation, deviation and CAPA management, and batch record review, APQR process and in process oversight. The role supports compliance with GMP and internal quality requirements, provides QA presence on the shop floor.Key ResponsibilitiesQuality Oversight & Production Compliance Conduct routine and unannounced GMP inspections in production areas (e.g., manufacturing lines, dispensing , gowning areas). Monitor compliance with GMP and GDP during manufacturing and packaging processes. Oversee effective implementation of line clearance, cleaning procedures, and in-process controls. Verify that environmental conditions (temperature, humidity, pressure differentials) are recorded and maintained within specifications.Batch Review & Product Release Review batch manufacturing and packaging records for completeness, accuracy, and compliance with process orders. Perform technical release of batches . Review cleaning logs, production logbooks, and chronological cleaning reports.Deviation, CAPA, and Change Control Manage and lead investigations for deviations, quality events, and complaints. Perform impact assessments, root cause analysis, and ensure timely closure of assigned CAPAs and deviations. Review, assess, and track change control requests related to production and cleaning processes.Validation & Cleaning Participate in planning and execution of process validation, cleaning validation, and batch-specific validation activities in coordination with production, validation and QA system Compliance. Review and approve validation protocols and reports within defined timelines.Audit & Inspection Readiness Actively support internal and external audits and regulatory inspections. Ensure availability of QA documentation and participate in audit responses and CAPA follow-up. Represent QA Operations during inspections.Documentation & Compliance Ensure compliance with GDP and data integrity principles in all quality-related documentation. Support document lifecycle activities (review, control, archiving) in the production QA scope.Training & Support Identify training needs for production and QA teams related to QA operations and ensure their execution in collaboration with QA Systems compliance. Supervise, mentor, and support QA Officers assigned to production oversight (team >3 associates).Cross-functional Support & Projects Interface with Production, Planning, QC, Regulatory, and Engineering to ensure timely resolution of quality issues. Support new product transfers and ensure QA readiness during transfers. Contribute to quality KPIs and participate in quality management reviews.Required QualificationsEducation Doctor of Pharmacy (PharmD) .Experience Minimum 5 years of experience in Quality Assurance in the pharmaceutical industry. Experience in batch record review, production oversight, deviation/CAPA management, and process validation. Prior experience in sterile or solid dosage manufacturing is an asset.Skills & Competencies Strong knowledge of GMP, GDP, process validation, and cleaning validation. Expertise in deviation investigation, CAPA systems, and batch documentation review. Proficient in SAP and electronic QMS tools. Skilled in risk assessment (e.g., FMEA), audit preparation, and cross-functional collaboration. Excellent communication, negotiation, and team leadership skills. Fluent in French, Arabic, and English.Performance Indicators (KPIs) On-time batch record review and product release. Timely closure of deviations, CAPAs, and complaints. Execution of daily shop floor inspections and follow-up. Effective QA support for process/cleaning validation activities. Contribution to site quality KPIs and regulatory compliance.

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سنوات الخبرة: Responsable d'Équipe, Manager / Responsable Département, Confirmé / Expérimenté

الفئات: الهندسة

وضع في: 24-06-2025 à 12:36:47