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Senior Quality Assurance Specialist with Environmental Expertise
2 mesi fa
Job Overview
A career-defining opportunity has emerged at the Healthcare Businesswomen's Association for a seasoned Quality Assurance Specialist with a deep understanding of environmental monitoring in the pharmaceutical industry/biotech sector. As we continue to drive excellence in quality management systems, we seek an individual who can effectively oversee production and testing activities while ensuring cGxP compliance.
Key Responsibilities:
- Oversight of all production and testing activities, guaranteeing adherence to cGxP requirements, including data integrity and eCompliance;
- Support exception investigations to promptly identify and address any issues that may arise;
- Review and approval of production, QC, and AS and T records to maintain accuracy and efficiency;
- Maintenance of Minimum Batch Records (MBR) to ensure seamless batch release processes;
- Collaboration on Operational Excellence (OpEx) improvement projects to drive continuous enhancement;
- Execution of batch release in compliance with registration requirements as a Qualified Person;
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt;
- Distribution of marketing samples (where applicable).
Performance Metrics:
- On-time and GMP-compliant release of dosage forms;
- No complaints about inspections by authorities in your area of responsibility without prior notification and communication;
- Successful support of continuous improvement projects;
- Accurate execution of batch release in compliance with registration.
Requirements:
- Work Experience: Proven functional breadth in QC/QA within the pharmaceutical industry/biotech sector, particularly in environmental monitoring;
- Collaborative mindset with ability to work across boundaries;
- Experience with cleanliness zones;
- Fundamental skills: Continuous learning, dealing with ambiguity, GMP procedures, QA, Quality Control (QC) testing, Quality standards, Self-awareness, Technological expertise, and Technological intelligence;
- Languages: English.
Estimated Salary Range: $120,000 - $150,000 per annum, commensurate with experience.