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As an Analyst – Quality Operations, your major accountabilities include:
- Oversight of all production and testing activities, ensuring compliance with cGxP standards, including data integrity and eCompliance.
- Support exception investigations and review and approval of production, QC, AS, and T records.
- Review of Master Batch Records (MBR) and support Operational Excellence (OpEx) improvement projects.
- Execute batch release in compliance with registration requirements.
- Reporting technical complaints, adverse events, and special case scenarios related to Novartis products within 24 hours of receipt.
- Distribution of marketing samples where applicable.
Key Performance Indicators:
- On-time and GMP-compliant release of dosage forms.
- No complaints about inspections by authorities in your area without prior notice and communication.
- Successfully support continuous improvement projects.
- Execute batch release in compliance with registration requirements.
Minimum Requirements:
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Work Experience:
- Experience in QC/QA roles within the pharmaceutical or biotech industry, including environmental monitoring and cleanliness zones.
Skills:
- Strong understanding of Quality Management Systems (QMS).
- Experience with Batch Manufacturing Record (BMR)/Batch Production Record (BPR) review.
- Knowledge of batch release processes and regulatory compliance checks.
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