Job Description

Summary Provide quality services in compliance with cGMP requirements and Novartis Quality Management System as defined and agreed between QOP and business partnersMajor accountabilities:

• 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
• Support to Stability management eg: Draft reports/assessments of temperature excursion assessments (TEA), transport category assignment (risk assessment (TRA)).

• 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:

• Continuous Learning.
• Dealing With Ambiguity.
• Gmp Procedures.
• QA (Quality Assurance).
• Quality Control (Qc) Testing.
• Self Awareness.
• Technological Expertise.
• Technological Intelligence.

Languages :

• Fluent in English (written and spoken)

Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Novartis