MS&T - Risk Assessments, CQV with Audit & Compliance

Job Description

Department MORAIYA Job posted on Jun 07, 2025 Employment type P-P8-Probationer-HO Executive Role name: MS&T - Risk Assessments, CQV with Audit & Compliance Division - Moraiya Department - MS&T Category - Staff Qualification - B.Pharma/M.Pharma Experience - 10+ Years Zydus Experience - Must have completed at least two PMS cycle. Job Responsibilities: · · Implement a systematic approach for enhancing the robustness of products and processes across these sites. Identify areas needing improvement and remediate the identified gaps through comprehensive design and process risk assessments. Conduct FMEA based risk assessments for evaluating Batch Size Increase proposals vide PAC checklists. Conduct FMEA based risk assessments for evaluating Operational Excellence and cost saving proposals. Institute best practices for Equipment and Facility Qualification – Lifecycle Management. Review qualification documentation, equivalency reports and related materials. Actively participate in Regulatory and Internal audits. Conduct self-inspections alongside the quality team. Provide technical expertise to troubleshoot and resolve outstanding issues during the product lifecycle management. Create standardized templates to harmonize practices across sites. Facilitate cross-functional discussion and foster alignment among stakeholders, including senior management. Ensure the timely completion of process risk assessments. Prepare detailed micro-plans for assigned projects. Collaborate closely with cross-functional teams to ensure tasks are completed within the designated timelines. Ensure compliance with established validation processes, Quality standards, SOPs, and other statutory requirements. Ensure that all activities adhere to cGxP standards, EHS and other relevant regulatory policies. Enforce adherence to the departmental training schedule. Undertake any additional responsibilities assigned as needed.