We are currently recruiting for a QA Pharmacist to join our dynamic team. Main Purpose of the Position: To Ensure compliance to national / international regulatory requirements with respect to Quality Management Systems and current Good Manufacturing Practices (cGMP). Ensure that all raw materials and packaging materials meet QC Standards, and cGMP requirements. Lead and manage all Quality activities in accordance with GxP and Operational requirements and to lead and manage technical functions and its people, ensuring products are manufactured, packaged and quality assured according to client specifications and regulatory requirements, efficiently and effectively, thereby contributing to the organization's strategic objectives. Matric. BSc Chemistry, BTech Chemistry, BTech Pharmaceutical Sciences, B Parm. Minimum 5 years' experience in pharmaceutical industry with exposure to QC, QA, Production, and Validation. Commitment. Accountability. Continuous improvement. Attention to details. Problem solving. Ability to multitask. Good communication skills. Ability to work independent and as part of the team. Knowledge of applicable quality guidelines and standards. Statistical analysis. Integrity. People management skills. Deviations: Ensures that there is a system in place for initiation, logging, review, classification, tracking, closure and filing of deviations. Customer Complaints: Ensures that there is a system in place for initiation, logging, review, classification, tracking, closure and filing of customer complaints. Non-Conformance Reports: Ensures that there is a system in place for deviation initiation, logging, review, classification, tracking, closure and filing of non-conformance reports. Change Control Management: Ensures that there is a system in place for deviation initiation, logging, review, classification, tracking, closure and filing of change control requests. Self-Inspection Management: Ensures that there is a system in place for self-inspection programme. Ensures that CAPAs are initiated for audit observations. Executes CAPA effectiveness. CAPAs: Ensures that there is a system in place for initiation, logging, review, classification, tracking, closure and filing of CAPAs. Product Quality Review: Ensures that PQRs are compiled and signed off according to the annual schedule. Vendor Management and Service Provider Management: Identification and qualification of new vendors/service providers. Conduct periodic and ad hoc vendor/service provider assessments and reviews. Ensures that TQAs and SALs are in place for all vendors/service providers. Training. Ensures that there is a system for planning, execution, evaluation and tracking of training. Identification of training needs. Regulatory Requirements: Ensures that all applications are made in time for all regulatory documents such as, GMP certificate, import permits, single exit price adjustment, Coordination of retention fee payments. Ensures that there is a procedure for filing and archiving regulatory documentation. Document Management: Ensures that a system for document filing and archiving of site GxP documentation. Retention Store Management: Ensures that there is a system for collection, inspection, review and control of retention samples for raw materials and finished products. Environmental Monitoring: Ensures compliance with the EM system. Coordination of resolutions or recommendations from the micro results/report. Pest Control Management: Ensures compliance to the pest control management system. Coordination of resolutions or recommendations from the micro results/report. Halaal System Management: Coordination of halal audits. Ensures resolution of observations. Validation and Qualification: Ensures that all validation and qualification activities are conducted in line with site procedures and GMP requirements. Coordinate resolution of validation deficiencies or findings observe during qualification and validation activities. Research and Development: Ensures that all new products are introduced in line with company procedures. Coordinate resolution of discrepancies observed during NPD. Risk Management: Ensure that risks to quality and compliance are considered, understood, and managed to an appropriate level in all operations. Ensures that there is a system in place for identification, assessment, analysis, and mitigation of all risks. Quality Monthly Review: Chairing of QMR meeting. Compilation of QMR report. Ensures CAPAs are raised in support of discussed quality deficiencies. Regulatory and External Audits: Ensures that audit findings are evaluated and addressed in a timely manner to determine if the operations are within a state of control. Evaluation of audit findings in comparison to internal policies. Any breakdown in the system or departure from procedures must be identified and rectified. Recalls and Mock Recalls: Coordinate product recalls and mock recalls as per company procedures and GMP requirements. Other Responsibilities: Periodic review of QA SOPs. Conduct training on QA related processes and procedures. QA Review of master documentation such as Batch manufacturing Records, Batch Packaging Records, Certificate of Conformance, Bulk Material Specification, Certificate of Analysis, Raw Materials Specification, Packaging Material Specification, protocols, etc. Generation of QA Score Card. Compiling QA related Reports as and when required. Any other tasks related to functioning of the QA department. Market Related Apply Now

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