Quality Assurance Specialist Abacus Parenteral Drugs Limited

Quality Management
• Development and maintenance of the organization’s Quality Management Systems in accordance with current applicable regulatory requirements and Internal Quality policy.
• To periodically review and update organizations standard policies and procedures in alignment with current regulations governing the pharmaceutical industry.
• Periodic review of all quality functions and procedures for appropriateness and validity.
• Periodic review and continuous improvement of existing SOPs, specifications and work systems with respect to current guidelines.
• Develop quality systems, procedures and amendments and monitor implementation and effectiveness of the same.
• Monitoring of compliance with the requirements of current Good Manufacturing Practices and internal procedures.

To approve or reject starting materials, packaging materials, intermediate, bulk and fished products IN THE ABSENCE OF THE QA manager.
• Provide quality guidance and participation in conducting Risk management activities, including, Risk identification, Risk analysis, FMEA, Risk mitigation and communication.
• Participate in investigation of recalled/returned products/complaints.
• To conduct the self-inspection and/or quality that regularly appraises the effectiveness and applicability of the quality assurance system.
• Conduct training with respect to GMP, GLP, Safety, hygiene, application and principles of Quality Assurance.
• Participate in vendor audit in order to qualify new suppliers and re-qualify existing suppliers.

Customer Service
• To provide the customers with adequate confidence that those goods, when received and used, will conform to their specifications/requirements and fully meet the customer’s and regulatory compliance requirements.

Records Management
• Retention and destruction of records.

Operational Controls
• To plan and execute QA activities within the budgeted resources effectively and efficiently