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Premium Employer

Sandoz

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4.0

based on 388 Reviews

373 Sandoz Jobs

Specialist - Quality Operations

Sandoz

4.0

based on 388 Reviews

4-7 years

Hyderabad / Secunderabad

1 vacancy

Specialist - Quality Operations

Sandoz

posted 2mon ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy QC Compliance SAP Quality Management Continuous Improvement GMP

+ 2 more

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.

Job Description

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, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Employment Type: Full Time, Permanent

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