Major accountabilities:

• Perform and deliver Quality Operations services in support of product quality compliance and regulatory workflows

• Support to QC release activities eg: Create, modify and review: Inspection Plans, Inspection Lot Numbers, Certificate Of Analysis, Certificate of Compliance, Specifications etc.

• Support to Testing Monograph management eg: Author testing monograph, Perform impact assessments etc.

• Authoring of risk evaluation reports for Nitrosamines both Step-1 & Step-2. Handling of risk evaluation reports with respect to country specific/local ones. Preforming authoring activity in Subway software. Data collection and slides preparation which are required for weekly work stream leads call/Steerco meetings.

• Perform Statistical support, Performance trending and Business support.

• 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

• Learn & develop understanding to generate insights through data and digital

• Provide active support during internal and external audits.

• Adhere to the current GxP and compliance policies of Novartis

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 

Minimum 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

Skills:

Quality Management System
GMP

Quality Control

Analytical Methods

Risk Assessment

Languages :

• Fluent in English (written and spoken)