Manager / Assistant Manager-Quality Assurance

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.

Desired Candidate Profile

Candidate should have B. Pharma, M. Pharma or any relevant specialization in Pharma