Sr.Manager/Manager-CQA || Medical Devices/Pharma || New Delhi

Roles and Responsibilities

• Planning and executing Audit of Vendors and its compliance base on Ranking and Filtering.
• Facility Qualification including Compressed Air, HVAC, Water System, Equipments/Instruments etc.
• Managerial decision on Change control, Deviation, CAPA, etc and other internal and external constraints.
• Monitoring of Validation and Qualifications activities of facilities with risk base approach, so that system remain in state of control.
• Preparation & Reviewing of Apex documents like Site Master File, Quality Manual, Validation Master Plan, Qualification, Validation & Calibration Calendar as per impact assessment of change control.
• Reviewing of Process Validation Protocols, Reports and risk assessment, giving training to execute protocol to process validation team on OSD formulation.
• Spearheading the entire investigations of deviation, OOS/OOT with root cause analysis using Quality tools.
• Reviewing and approval of change control related impacting documents, process and activities.
• Reviewing of Analytical reports including Audit trail, OOS/OOT investigation, disregard as responsible for AQA activity.
• Resolving product and process related problems in coordination with product development laboratory personnel.
• Reviewing and approval of Qualification documents as per regulatory requirements of equipments, instruments, HVAC System, Water System and other utilities, giving training to Execute protocol to Qualification and validation team.
• Enhancing & focusing on harmonization of Quality System with continual improvement by reducing gaps as per cGxP/GAMP and regulatory requirements.
• Planning and executing Audit of Vendors and its compliance base on Ranking and Filtering.
• Reviewing of SOPs and other cGMP documents, data integrity as per regulatory and statutory guidelines.