Associate Manager MQA
On-siteVisakhapatnam, Andhra Pradesh, India
Job Summary
Ensure cGMP compliance in Terminal Sterilization, Visual Inspection, and Packaging operations by reviewing batch reports, equipment audit trails, and AMPS exceptions. Perform acceptable quality level sampling, inspection, and record results in batch records while conducting daily walkthroughs and random process checks. Execute batch start-up and end activities, including sensor challenge tests and recipe reviews, alongside equipment breakdown assessments and alarm trend analysis. Identify gaps to simplify processes, reduce downtime, and increase efficiency through proactive problem-solving and technical support. Handle regulatory, corporate, and internal auditor inspections while mentoring colleagues and leveraging AI tools for productivity.
Required Qualifications
- B. Pharm, M. Pharm, MSc.
- 6-8 years of experience in Manufacturing Quality Assurance / Quality Assurance / Production of a pharmaceutical manufacturing facility
- Fundamental knowledge of terminal sterilization process/ Visual Inspection/Packaging
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Proactive approach to problem-solving
- Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship
- Acts Decisively: Makes decision in a timely manner based on available information
- Grows Self: Identify Individual development needs and create a plan and work towards achieving those objectives
- Critical thinking and Compliance mind set
Desired Qualifications
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
- 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
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