Quality Associate Analyst

Contract Provider

: Associate Analyst – Quality Operations

: Randstad India Private Ltd.

Department : Quality Operations Partner

Reporting Manager title : Team Lead – Quality Operations

Entry date in new role : DD-MMM-YYYY

Job Purpose

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.

Major Accountabilities

 Comply with internal functional requirements such as KPI reporting, ticket management tools and any

other internal procedures and processes.

 Assist the department with any other ad hoc activities/ requests to meet the business requirements.

 Focus on timely completion of all relevant and assigned trainings.

 Learn, develop & leverage data and digital tools to build understanding and generate insights that

support quality operations and decision-making as needed.

 Ensure responsibility and ownership of the assigned tasks and comply with accuracy and timeliness of

deliverables.

 Comply to the applicable Novartis operating procedures as per legal/ IT/ P&O requirements

 Provide active support during internal and external audits by collecting and presenting the requested

process/ data and reports.

 Adherence to the current GxP and compliance policies of Novartis Perform and deliver Quality

Operations in support of product quality compliance and regulatory workflows.

 Hold accounts in workflow applications to ensure appropriate execution of process deliverables, using

approved enterprise platforms as applicable.

 Escalate process related GxP and non-GxP issues and ensure timely investigation and compliance with

local and global operating procedures.

 Ensure compliance to the Novartis internal quality standards, relevant regulatory requirements and any

filed product quality standards.

 Engage regularly with business partners to gather feedback on the support provided and deliverables,

ensuring continuous improvement and alignment with operational needs.

 Support the Master Data Management to the required sites as needed.

 Manage various types of change controls (e.g., Product, Asset, and others) using Novartis-approved

digital platforms from initiation to closure, as applicable.

 Generate and analyze predefined and ad-hoc reports using authorized enterprise applications and

perform follow-up actions as needed.

 Perform designated roles such as Entity Data Manager, Business Approver, P31 Module Approver,

CRB Facilitator, Key User, and NCQ Non-Duplication Activity, based on business requirements.

 Provide governance support as needed.

Job Dimensions (Indicate key facts and figures)

Number of Associates: NA Direct: NA

Financial responsibility: NA Indirect: NA

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Ideal Background / Requirements for the role

• M. Pharm/ MBA / Engineering/equivalent from a reputed institute

• Common requirements for experienced associates

• Min. 0-2 yrs Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug

substances /products/Medical device

• Basic computer skills