Associate Manager - QA
- Pfizer
- 8 - 10 years
- Visakhapatnam
- 3 days ago
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Job Description
Use Your Power for Purpose
Every day, Pfizer s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
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Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
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Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
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Approve investigations and change control activities to maintain compliance with configuration management policies.
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Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
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Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
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Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
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Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Here Is What You Need (Minimum Requirements)
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Education Qualification: B. Pharm / M. Pharm / M. Sc (Any Specialization)
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Experience: 8 - 10 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility.
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Responsible for ensuring operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations.
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Maintain regulatory compliance in accordance with cGMP practices
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Ensure manufacturing policies, procedures conform to Pfizer
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SME for Terminal Sterilization/Visual Inspection/Packing.
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Knowledge and hands on experience in reviewing eBR.
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Perform random process checks for Terminal Sterilization, Visual Inspection and Packaging
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Perform Daily walkthroughs and report observations to the Supervisor and ensure appropriate closure of those incidents
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To provide trainings to colleagues on Terminal Sterilization/Visual Inspection/Packing process and equipment.
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Report any non-compliance to the Supervisor
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To perform manufacturing investigations, implementation of CAPAs and to provide support to other investigators for technical inputs.
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Provides guidance to and may lead moderate to complex projects
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Identify gaps and involve in Process and Procedure Simplification, thereby reduce downtime and increase the Efficiency.
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Should have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
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Experience in handling regulatory, corporate and internal auditors/ inspectors
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Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
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Strong critical thinking skills
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Ability to work effectively within own team and interdepartmental teams
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Good working knowledge of Microsoft Excel and Word
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Proactive approach to problem-solving
Bonus Points If You Have (Preferred Requirements)
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Experience in quality administered systems
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Strong organizational skills and attention to detail
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Experience with regulatory compliance and documentation
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Ability to mentor and review the work of other colleagues
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Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
Quality Assurance and Control
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: Manager Quality Assurance Quality Assurance Lead Pharma Configuration management Packaging Regulatory compliance Inspection Risk management microsoft Operations
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