QA Analyst Yogi Intermediates Pvt Ltd

About Yogi Intermediates Pvt Ltd

Job Description

Job Title Quality Assurance (QA) Documentation Executive Department- Quality Assurance (QA) Geography Covered- Panoli Plant, Gujarat, India Reports To: Direct: QA Manager - Matrix: Head of Quality & Compliance Job Summary The QA Documentation Executive is responsible for ensuring all quality-related documents, records, and compliance materials are properly maintained, updated, and aligned with industry standards and regulatory requirements. This role plays a critical part in supporting audits, implementing quality procedures, and fostering a compliance-driven culture. General Duties & Responsibilities Document Control & Compliance: Manage, review, and update QA documents, SOPs, batch records, and test reports. Regulatory Compliance: Ensure adherence to ISO, GMP, FDA, and other chemical industry regulations. Audit Preparation: Organize and maintain documentation for internal & external audits. Training Support: Assist in training employees on document control and compliance standards. Data Integrity & Security: Safeguard quality data and maintain version control. Key Result Areas (KRAs) & Description Document Control & Management Maintain up-to-date and error-free QA documents, ensuring version control. Regulatory Compliance Ensure all documents comply with legal and industry standards (ISO, GMP, FDA, etc.). SOP Development & Maintenance Develop, review, and standardize Standard Operating Procedures (SOPs). Internal & External Audits Prepare QA documentation and ensure readiness for audits. Training & Awareness Conduct periodic training sessions on documentation standards and compliance. Change Control Process Manage and document changes in processes and regulations. Non-Conformance & CAPA Documentation Maintain records of non-conformities and track Corrective and Preventive Actions (CAPA). Quality Review & Approvals Support QA/QC teams in reviewing batch records, test reports, and deviations. Continuous Improvement Identify areas for improvement and implement best practices in documentation. Data Integrity & Security Ensure the confidentiality and security of quality-related records. Key Performance Indicators (KPIs) & Description Document Accuracy (%) Percentage of QA documents without errors or missing information. Regulatory Compliance Score Measured through audit scores and adherence to industry regulations. SOP Update Frequency (%) Timely review and update of SOPs per schedule. Audit Readiness Level (%) Number of successful internal and external audits with minimal non-conformances. Training Completion Rate (%) Percentage of employees trained on documentation protocols. Change Control Efficiency (%) Time taken to document and implement approved changes. CAPA Closure Rate (%) Percentage of Corrective and Preventive Actions closed within the target timeline. Quality Review Turnaround Time (TAT) Time taken to review and approve documents. Error Reduction in Documentation (%) Decrease in document-related errors year-over-year. Data Integrity Compliance (%) Compliance with data security and integrity protocols. Competency Metrics (KASH Model) Knowledge (K): Regulatory guidelines (ISO, GMP, FDA), Document Management System (DMS), SOPs, Audit processes. Attitude (A): Attention to detail, Compliance-oriented, Team player, Proactive approach. Skill (S): Technical writing, Document control, Data analysis, Audit preparation. Habit (H): Consistency in documentation, Accuracy, Timeliness, Ethical compliance. Education & Experience Education: Bachelor's/masters degree in chemistry, Chemical Engineering, Pharmacy, Microbiology, or related field. Experience: 3-5 years of experience in QA documentation, regulatory compliance, and audit preparation in the chemical industry. Technical Proficiency: Familiarity with ERP, DMS, QMS software, and proficiency in MS Office (Excel, Word, PowerPoint). Job Type: Full-time Benefits: Health insurance Life insurance Provident Fund Schedule: Day shift Morning shift Rotational shift Performance bonus Yearly bonus Work Location: In person Speak with the employer +91 9586274866 Application Deadline: 15/03/2025 Expected Start Date: 13/03/2025,