Officer - Quality Assurance

2 weeks ago

Bharuch Gujarat, India SDP HR Solution Full time

REQUIREMENTS Education Experience Education BSC MSC Chemistry Experience 2-3 years in Pharma industry with awareness of Quality management systems manufacturing activities process validation Qualification Regulatory requirements JOB PURPOSE Generic Implement Quality Assurance activities for Pharmaceutical at Dahej adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products to meet with customers requirements living Group s Values and Code of Ethics Specific additions if needed KEY ACCOUNTABILITIES Quality Management Continuous Improvement Line Clearance and shop floor compliance Assisting in Complaint Investigation system at site Assisting in Qualification and validation system change control system deviations Preparing review the Annual Product Quality Review Review of Batch Manufacturing Packing Records Coordination of cGMP Training activity Compliance Ensure adherence to company Quality Standards Local FDA MHRA regulations by Understanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations Qualifications Ensure validated status of all equipment s manufacturing processes and cleaning processes Review of protocols for qualification and validation of facility equipment product process Review of validation reports after execution of validation of facility equipment product process Documentation Control Preparation and Review of SOPs Controlled distribution and archival of documents record Control of master documents Assuring quality of products by Ensuring SOP compliance Review of Batch Manufacturing Packing Records Ensuring implementation of Corrective actions Preventive actions proposed in Deviations and Customer complaints Ensuring the effectiveness review of the implemented CAPA cGMP Training To prepare training modules and organize training in GMP Execute the training program in coordination with all concerned departments Other Review of maintenance and calibration program Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations

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