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Specialist - Quality Operations

AT Novartis
Novartis

Specialist - Quality Operations

Hyderabad, India

Summary

-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)

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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.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Division
Operations

Business Unit
Innovative Medicines

Location
India

Site
Hyderabad (Office)

Company / Legal Entity
IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Alternative Location 1
Telangana, India

Functional Area
Quality

Job Type
Full time

Employment Type
Regular

Shift Work
No

Client-provided location(s): Hyderabad, Telangana, India
Job ID: Novartis-REQ-10015156
Employment Type: Full Time