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Job Description Summary
-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems.
Job Description
Major accountabilities:
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance -Support exception investigations -Review and approval of production, QC, and AS and T records -MBR review -Support OpEx improvement projects Qualified Person – Executes batch release in compliance with registration -Reporting of technical complaints / adverse events / 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 own area of responsibility without these being noticed and communicated beforehand -Successfully support continuous improvement projects -Executes batch release in compliance with registration
Minimum Requirements:
Work Experience:
- Functional Breadth.
- QC/ QA in pharmaceutical ind./ biotech with environmental monitoring &.
- Collaborating across boundaries.
- cleanliness zones.
Skills:
QMS
BMR/ BPR review
Batch Release process
Quality Management
Regulatory compliance checks
Languages :
- English.
Skills Desired
Continuous Learning, Gmp Procedures, Managing Ambiguity, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technical Knowledge, Technological Intelligence
Novartis Hyderabad, Telangana, IND Office
Salarpuria-Sattva Knowledge City, Inorbit Mall Rd, Durgam Cheruvu Rd, HITEC City, Hyderabad, Telangana, India, 500081
What you need to know about the Hyderabad Tech Scene
Because of its proximity to leading research institutions and a government committed to the city's growth, Hyderabad's tech scene is booming. With plans to establish India's first "AI city," the city is on track to become one of the world's most anticipated tech hubs, with companies like TransUnion, Schrödinger and Freshworks, among others, already calling the city home.
