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Novartis

Compare

4.1

based on 1.5k Reviews

282 Novartis Jobs

Specialist-Quality Operations

Novartis Healthcare Pvt. Ltd.

4.1

based on 1.5k Reviews

1-4 years

Hyderabad / Secunderabad

1 vacancy

Specialist-Quality Operations

Novartis

posted 15d ago

Job Role Insights

Flexible timing

Key skills for the job

Pharmacy SAP CO Packaging Compliance Agile Coaching PLM Teamcenter

+ 3 more

Job Description

Summary

Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partners.

About the Role

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.

Major accountabilities:

Common Accountabilities (Applicable to all service teams)

Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows
Hold accounts in workflow applications (such as SAP, Dragon, SUBWAY, etc.) to ensure appropriate execution of service deliverables
Generate and analyse predefined and ad-hoc reports in various applications (like AGILE PLM, AQWA etc.) and perform follow-up actions if required
Escalate service 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, filed product quality standards and service level agreements
Comply with all internal functional operating procedures like time tracking, KPI reporting, ticket management tools and other internal systems and processes
Assist the department on any other ad hoc administrative activities as per business requirements.
Focus on timely completion of all relevant and assigned trainings
Learn & develop understanding to generate insights through data and digital
Ensure responsibility and ownership of the assigned tasks
Comply the accuracy and timeliness of deliverables
Comply to the applicable Novartis operating procedures as per legal / IT / HR requirement
Provide active support during internal and external audits by collecting and presenting the requested process data/reports
Adhere to the current GxP and compliance policies of Novartis.

Key performance indicators:

Extract data from relevant sources in Novartis tools/ applications.
Interpret and compile external supplier APQR and/ or extracted data from Internal Novartis systems into a pre-defined template and draft conclusion of product quality review.
Collect contributory reports for product related evaluations.
Interact with CMOs and / or manufacturing sites as required.
Support in updating and maintenance of APQR schedule.
Perform review of APQR report/ data as applicable to ensure it is complete and correct.
Complete APQRs within defined timelines.
Archive the approved APQR as applicable
Update APQR data in e-compass file followed by interpretation of data to conclude product robustness.
Marketing Authorization Holder (MAH) Review:
Support in maintenance of MAH/BRS review schedule
Coordinate with NCQ SPoCs and/ or manufacturing/ packaging/ testing/ batch releasing sites as required to draft MAH/BRS checklist
Extract data from relevant sources as applicable and compile MAH/BRS as per the requirements in a predefined format
Interpretation and consolidation of the data
Review for accuracy and completeness of compiled data /information
Submit the drafted MAH/BRS reviews for approval to respective Country quality team
Archive the approved MAH/BRS review documents

Education Background:

M.Pharm/ MBA / Engineering/equivalent from a reputed institute.
Min 1 yr Experience in Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ Medical device.
Basic awareness of GxP compliance requirements.

Employment Type: Full Time, Permanent

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