MQA Upstream Specialist - Visakhapatnam/Vizag @ Pfizer

Job Description

Job description

• Responsible for ensuring 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 startup and inprocess activities 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 trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.

Qualification

• B.Pharm / M. Pharm / M.Sc (Any specialization)

Job Classification

Industry: Construction, Engineering, Cement, Metals
Functional Area: Production, Manufacturing, Maintenance,
Role Category: Production/Manufacturing/Maintenance
Role: Production/Manufacturing/Maintenance
Employement Type: Full time

Education

Under Graduation: Any Graduate in Any Specialization
Post Graduation: MS/M.Sc(Science) in Chemistry
Doctorate: Doctorate Not Required

Contact Details:

Company: Pfizer
Location(s): Visakhapatnam

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Keyskills:   Product quality Supervisor Manager Quality Assurance Manufacturing quality Regulatory compliance Troubleshooting Technical support Monitoring Auditing