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Novartis

Compare

4.1

based on 1.6k Reviews

234 Novartis Jobs

Specialist - Quality Operations

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.6k Reviews

3-5 years

Hyderabad / Secunderabad

1 vacancy

Specialist - Quality Operations

Novartis

posted 2d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy SAP CO Data Analysis Analytical Chemistry Medical Devices GMP

Job Description

About the Role:

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners. Manage Quality aspects & projects within area of responsibility.

Key Responsibilities:

Coordination and management of analytical method transfers and stability studies. Compilation of data reports
Life-cycle management of analytical methods, including control of method performance, pharmacopoeia and health authority compliance and definition of method improvements. Handling of deviations, investigation, OOS/OOE/OOT cases as well as changes and complaints
Perform statistical data analysis to report Out of Expectations (OOE), out of trends (OOT), etc
SAP master data management: Maintenance of master data, creation of Q-info records and other SAP related activities.
Validate spreadsheets
Collect, transcribe and/or compile data from various repositories (SAP, LIMS, external COAs)
Author, approve and archive Impurity risk assessments - Nitrosamines, residual solvents, etc
Trend and report all QMS elements as per the request
Monitor, trend and report Health Safety and Environmental parameters
Implementation of GMP requirements. Compilation and Review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents (Common Technical Document modules)).
Perform activities of a Quality Control expert as defined by the respective sites
Support regulatory requirements - routine queries, Chromatogram requests
Compile Quality performance management decks
Create and review GxP documents including SOPs, working procedures, trend reports, qualification reports and technical investigations, as and when needed

Essential Requirements:

Pharmacy/ Science/ MBA / Engineering/ equivalent from a reputed institute
Min 3 years of experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances/ products/ medical devices
GxP knowledge, Basic IT knowledge
Good communication, presentation and interpersonal skills
Experience of working closely with the global stakeholders

Employment Type: Full Time, Permanent

Read full job description

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