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Pfizer
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Associate Manufacturing Quality Assurance

Associate Manufacturing Quality Assurance

Pfizer

2 - 6 years

5 - 6 Lacs

visakhapatnam

Posted:5 days ago| Platform:

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Skills Required

product quality manager quality assurance compliance manufacturing quality pharma packaging inspection technical support downstream auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Manufacturing Quality Downstream Associate is responsible for primary contact of quality on the floor, particularly in the Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards

Responsibilities

Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging 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
Associate or Sr Team Leader

Review of Batch reports and Equipment audit trails

Perform Acceptable Quality level sampling, Inspection in VIDT and Batch record review and release

Perform batch start-up and end activities viz
sensor challenge tests, recipe review etc

Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging

Perform Daily walkthroughs and report observations to the Sr
Team Leader

Perform Equipment breakdown assessments wrt to Product Quality and patient safety with technical support/inputs from Sr
Associate or Sr Team Leader

Review and assessment of equipment alarms and review of quarterly alarm trends

Report any non-compliance to the Sr Associate or Sr Team Leader

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

Here Is What You Need (Minimum Requirements)

2 -6 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility
Experience in the pharmaceutical industry and Quality administered systems
Sound knowledge of current Good Manufacturing Practices (part of GxP)
Ability to work effectively in a team environment, both within ones own team and interdepartmental teams
Effective written and oral communication skills

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Pfizer

Pharmaceutical Manufacturing

New York New York

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Associate Manufacturing Quality Assurance