Job Overview
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Date PostedJuly 28, 2023
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Location (State / UT)
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Expiration date--
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Experience1 Year, 5 Years
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GenderAny
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Desired QualificationBachelor 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.