AS&T Specialist - Quality Operations at Novartis

, Telangana, India -

Full Time

Start Date

Immediate

Expiry Date

03 Oct, 26

Salary

0.0

Posted On

05 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Collaboration, Communication Skills, Data Integrity, Leadership, Managing Ambiguity, Operational Excellence, Problem Solving Skills, Regulatory Requirements Knowledge

Industry

Pharmaceutical Manufacturing

Description

Job Description Summary Perform analytical tasks in responsibility of AS&T group to support AS&T Experts in overall management of their projects. Ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Support analytical Life Cycle Management for commercial products and support timely analytical implementation for new projects. Job Description Major Accountabilities: Support management of all analytical activities related to projects within in responsibility of AS&T group· Support Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance (support subject matter expert in health authority inspections) · Single point of contact for internal and external clients and contract laboratories, if applicable. Support timely analytical implementation (Method Transfer and Method Validation) for (new) projects in the course of product transfers· Setup and monitoring of stability studies· Support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T· Support implementation of GMP requirements. Support compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents) Key Performance Indicators: Stakeholder orientation and collaboration On time and accurately completion of deliverables as per the responsibilities delegated Efficiency and Productivity metrics Process improvements Quality Compliance Problem solving skills and Troubleshooting Data Integrity Regulatory requirements knowledge Project Management Communication skills Continuous Learning. Minimum Requirements: Education: M.Pharm/ MBA / Engineering/equivalent from a reputed institute. Basic awareness of GxP compliance requirements. Languages: English Experiences: Minimum 5-6 years’ experience in Quality Assurance, Quality Control, Regulatory or in the manufacturing of pharmaceutical drug substances or products/ medical device/ expertise in Learning management system Languages: English. Skills Desired Collaboration, Communication Skills (Inactive), Data Integrity, Digital saviness (Inactive), Leadership, Managing Ambiguity, Operational Excellence, Problem Solving Skills (Inactive), Regulatory Requirements knowledge (Inactive) Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. Novartis is aware of employment scams which make false use of our company name or leader’s names or recruiter’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information. Novartis is not responsible for any claims, losses, damages, or expenses resulting from scams. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

Perform analytical tasks to support AS&T experts in project management and ensure compliance with cGMP and regulatory requirements. Manage analytical life cycle activities, including method transfer, validation, and stability studies for commercial products.