Associate Quality Assurance | Pfizer | Vizag

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Job Overview

  • Date Posted
    July 28, 2023
  • Location (State / UT)
  • Expiration date
    --
  • Experience
    1 Year, 5 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree, Master’s Degree

Job Description

Roles and 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 a 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 and adherence manufacturing practices with respective standards and approved procedures.
  • Perform daily walk-throughs and report observations to the supervisors and ensure appropriate closer of those incidents.
  • Perform equipment breakdown assessments w.r.t to product quality and patient safety independently.
  • 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 process and procedure simplification, thereby reducing downtime and increasing efficiency.
  • Experience in handling regulatory, corporate, and internal auditors/inspectors.
  • Responsible for assisting manufacturing investigators w.r.t collection of data, information, and technical support and may perform in conducting investigations.

Desired Profile:

Education: B. Pharma / M. Pharma / M.Sc.

Experience: 1-5 years experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.