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Specialist - Quality Operations

Specialist - Quality Operations

NOVARTIS

1 - 6 years

7 - 8 Lacs

Hyderabad

Posted:1 month ago| Platform:

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Skills Required

OPEX QC Networking Pharma Regulatory compliance data integrity GMP Continuous improvement Environmental monitoring Quality management

Work Mode

Work from Office

Job Type

Full Time

Job Description

-Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems. About the Role 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.

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NOVARTIS

Pharmaceutical Manufacturing

Basel Baselstadt

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Specialist - Quality Operations