Associate MQA Downstream
- Pfizer
- 5 - 7 years
- Visakhapatnam
- 6 days ago
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Job Description
Responsibilities:
- Responsible for primary contact of quality on the floor, particularly in the Visual Inspection Training, Terminal sterilization, Visual Inspection and Packing areas of production and monitor processes for compliance to cGMP standards.
- 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 w. r. t 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
- Trouble shooting in 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 reduce downtime, and increase the Efficiency
Here Is What You Need (Minimum Requirements)
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BSC or B-Pharma / B-Tech with 5-7 years of experience
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Experience working in a Pharmaceutical Company
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Experience in the pharmaceutical industry and Quality administered systems
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Sound knowledge of current Good Manufacturing Practices (part of GxP)
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Ability to work effectively in a team environment, both within ones own team and interdepartmental teams
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Effective written and oral communication skills
Bonus Points If You Have (Preferred Requirements)
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Experience at a manufacturing site.
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Managing and writing deviations
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Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
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Strong problem-solving skills
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Ability to work independently and as part of a team
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Excellent time management and multitasking abilities
Quality Assurance and Control
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Customer Success, Service & OperationsRole Category: Customer SuccessRole: Customer Success AssociateEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: Product quality ERP Manager Quality Assurance Compliance Pharma Packaging Inspection Technical support Downstream Auditing
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