Quality Operations Specialist / Analyst

Specialist/Analyst - Quality operations

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. Manage Quality aspects & projects within area of responsibility. Support manufacturing sites with QC and related activities.

Job Description

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)

Skills Desired

Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Leadership, Operational Excellence, Problem Solving Skills, Regulatory Requirements knowledge

Experience Level

Mid Level