ASSISTANT MANAGER QUALITY ASSURANCE
AGP Limited
Total des années d'expérience :1 years, 11 Mois
• Conducted quality audits and assessments to identify improvement areas and drive corrective actions.
• Led training sessions on quality assurance procedures and best practices, while developing and maintaining quality management systems to ensure compliance with industry standards.
• Managed Quality Risk Management, deviations, product technical complaints, and related follow-up activities.
• Established and executed inspection, testing, and evaluation protocols to ensure product and production equipment precision and accuracy.
• Managed nonconformities, change controls, market complaints, supplier evaluations, and complaints.
• Ensured compliance with Good Documentation Practices (GDP) and Good Laboratory Practices (GLP) across departments, and drafted and reviewed documents for final approval.
• Monitored departmental adherence to quality objectives, prepared management review meetings, and generated customer feedback reports.
• Monitored Quality Key Performance Indicators (KPIs) and laboratory KPIs, provided hands on training for personnel in quality assurance procedures, managed stock control, and supported future expansion/upgrade projects.
• Audited quality systems to identify and correct deficiencies, reviewed testing reports, and provided analysis and feedback.
• Supervised equipment calibration, prepared yearly planner of calibration and qualification management activities, developed and maintained training and qualification programs, and supported future projects.
• Developed and maintained a training and qualification program for media-filled batch reconciliation and reviewed reports.
• Served as a technical expert leading investigations into OOS, OOL/OOT, microbial contamination, adverse trends, utility and environmental excursions, change controls, and CAPAs.
• Prepared technical documents including methods protocols, qualification/validation protocols and reports, SOPs, and supported risk assessments for projects and business innovation initiatives from a microbiological perspective.
• Performed aseptic techniques for crucial process steps, provided meaningful input to processing operations, and kept abreast of corporate and regulatory trends and requirements.
• Perform different tests, analysis, and evaluates the Raw materials, Intermediate products, Finish products, Oral Solid Dosage and Sterile products and after computing their results, release on SAP.
• Manage and Design SOPs, Protocols & Reports for IQ, OQ, PQ and Validate the excel spread sheet as per cGMP compliance.
• To effectuate and ensure on time preventive maintenance, verification and internal/external calibration and qualification of various instruments including Autoclave, Dry Heat Oven, Incubator and Analytical Balance.
• Document compilation of OOS, OOT and atypical result, and in case of failure complete investigation (Phase I, II & III) for identification of root cause and taking CAPAs (Corrective and Preventive actions) to proceed accordingly.
• Perform activities related to Quality Management System.
• Strong technical skills relating to writing new procedures, maintaining databases, and process validations. Experienced with investigations related to non-conformances, deviations, and corrective actions.
• Participate in the qualification of ISO/IEC/17025 Lab Accreditation.
• Responsible for Qualification and analysis of all type of pharmaceutical water system such as WFI, Purified water, Drinking water, R.O Water (Reverse Osmosis) and Potable Water.
• Executed cleaning validations for manufacturing equipment.
• Conduct proficiency testing (PT-sample) facilitated by LGC Axio, contributing to ISO/IEC/17025 Lab Accreditation.