MQA Upstream Specialist | Pfizer | Vizag

Job Description

Role & Responsibilities:

• Responsible for ensuring the operating state of cGMP compliance in solution/emulsion preparation, vial/ampoule washing, depyrogenation, filling, and capping operations.
• Maintain regulatory compliance in accordance with cGMP practices.
• Ensure manufacturing policies and procedures conform to Pfizer standards.
• Knowledge and hands-on experience in reviewing eBR and assessing the impact of AMPs exceptions with technical support/inputs from Sr. Specialist or Supervisor.
• Review of batch reports and equipment audit trails.
• Perform EMS alarm impact assessments and monthly trend reports.
• Ensure start-up and in-process activities are performed as per batch record and SOP compliance.
• Monitor the manufacturing practices and ensure compliance with respect to standards and approved procedures.
• Perform daily walk-throughs and report observations to the supervisors.
• Perform equipment breakdown assessments w.r.t to product quality and patient safety with technical support/inputs from Sr. Specialist or Supervisor.
• Review and approval of equipment alarms and review of alarm trends.
• Report any non-compliance to the supervisor.
• Should have troubleshooting abilities in the manufacturing area, which helps the organization develop, implement and achieve its mission, vision, and values.
• Identify gaps and involve in the process and procedure simplification, thereby reducing downtime and increasing efficiency.

Qualifications

• 0-2 years experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.
• B. Pharma / M. Pharma / M.Sc.