Specialist - Quality Operations

1 day ago


Hyderabad Office, India Novartis Full time ₹ 4,00,000 - ₹ 12,00,000 per year

Band

Level 3

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

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