Prepare for Your Novartis Interview with Real Experiences!
View interviews
Get AmbitionBox App
Faster and better experience!
AmbitionBox
Search
Jobs
- Reviews
- Salaries
- Interview Questions
- About Company
- Benefits
- Jobs
- Office Photos
- Community
Add office photos
All Filters
275 Novartis Jobs
QA Specialist QMS Support
Novartis
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Manages Quality aspects and projects within area of responsibility. -Ensures and supports overall GxP conformity and Compliance with the Novartis Quality Management Systems
Key Responsibilities:
Ensure timely collection of required documents and information for document based GMP compliance inspection of manufacturing sites registered in Japan. Efficient communication with relevant stakeholders and manufacturing sites in timely manner.
Support the following regulatory compliance activity under GQP/QMS. Work together and communicate effectively with manufacturing sites and other line functions to keep the compliance of Japan approval files for the products undergoing the following type of inspections:
Partial Change Application (PCA) inspections: for any changes post approval of drug New Drug Application (NDA) inspections: for new drug approvals Periodic inspections: conducted for manufacturing sites every five years
Proper collection of required information and share with relevant stakeholders Proper and efficient handling of information Rapid and proper management of critical information Proper cooperation with Novartis Japan NCQ members Status monitoring and trend of document collection timelines Report to Quality Assurance Supervisor in Japan Review collected documents and contents checks
Ensure that a timely, effective, continuous quality improvement in corroboration with relevant stakeholders.
Support projects of new product launch and product transfer.
Provide support for the preparation and follow-up of GMP inspections at the Country Japan
Ensure that a local Quality System and Standard Operating Procedures are in place for all GxP related activities and that compliance with cGMP is maintained through training and internal audits.
- Ensures the timely collection, monitoring, and reporting of Quality Key Performance Indicators (KPIs) for management reporting Assists in Health Authority inspections and internal audits by supplying information and documentation in a timely manner -Support and track the implementation and maintenance of the local Quality system in in accordance with the Novartis Quality Manual -Manages processes and systems for all GxP Quality Assurance eg Change control, Training Management, Escalation Management, Risk Management.
- Ensures that processes are conducted in full compliance with the GxP and the Novartis Quality.
- Contributes to an improvement of current processes and/or to an implementation of modified processes.
- Ensures adequate tracking and on time completion of corrective and preventive actions (CAPA), inc escalation of issue related to the closure of CAPA, as appropriate.
- Review quality deliverables to ensure compliance, with health authority requirements and SOPs, including procedural documents, records, third party work, contractors, clinical trial material, components, and gap assessments -Prepare and review GxP documentation; assists in the release of GxP documentation, filing and archiving of GxP documentation -Supports Compliance review of projects and inspection readiness and management -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Essential Requirements:
- Quality standards are understood, designed into work activity, andachieved.
- In accordance with departmental objectives such as support ofprojects with agreed quality and delivery date, passing of internal and external inspections
- Local GxP Quality systems in place and maintained.
- GxP risks proactively identified and effectively mitigated.
- Number of severity of GxP/DI issues identified during internal/external audits and timeliness of collection of required information.
- Timely completion of assigned activities.
- No critical observations from internal audits or Health Authority Inspections
Desirable Requirements:
Work Experience:
- Functional Breadth.
Skills:
- Compliance Requirements.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Gxp.
- Industry Standards.
- Project Management.
- Quality Management Systems (Qms).
- Quality Standards.
- Risk Management.
- Self Awareness.
- Technological Expertise.
Languages :
- English.
Employment Type: Full Time, Permanent
Read full job description
What people at Novartis are saying
Rating based on 1 QA Specialist
review
Anonymous · Other
in Hyderabad / Secunderabad
Likes
They conduct Fake interviews
Dislikes
Screen the profile carefully then call for interview, don't do fake interview
- Salary - Bad
+6 more
QA Specialist salary at Novartis
reported by
2
employees
with 9-12
years exp.
₹9.9
L/yr - ₹12.7
L/yr
At par with the average QA Specialist Salary in India
View more details
What Novartis employees are saying about work life
based on 1.7k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
View more benefits
Compare Novartis with
Cipla
Compare
Dr. Reddy's
Compare
Lupin
Compare
Zydus Lifesciences
Compare
Sun Pharmaceutical Industries
Compare
Aurobindo Pharma
Compare
Intas Pharmaceuticals
Compare
Macleods Pharmaceuticals
Compare
Hetero
Compare
Viatris
Compare
Abbott
Compare
Ipca Laboratories
Compare
Glenmark Pharmaceuticals
Compare
Alkem Laboratories
Compare
Torrent Pharmaceuticals
Compare
Mankind Pharma
Compare
MSN Laboratories
Compare
Akums Drugs & Pharmaceuticals Limited
Compare
GlaxoSmithKline Pharmaceuticals
Compare
Pfizer
Compare
Similar Jobs for you
Novartis Mumbai Office Location
Mumbai Office
Novartis India Ltd, Sandoz House, Shivsagar Estate, Dr Annie Besant Road, Worli
Mumbai
Maharashtra 400018
Maharashtra 400018
Senior MarTech Data Analyst - Salesforce Marketing Cloud
4-8 Yrs
Hyderabad / Secunderabad
Digital Finance, Manager (Analytics Operations)
5-10 Yrs
Hyderabad / Secunderabad
Project Manager DDIT Dev. RA
10-15 Yrs
₹ 10 - 17L/yr (AmbitionBox estimate)
Hyderabad / Secunderabad
Assoc. Dir. DDIT US&I Sol.Del.Analytics Prod
10-15 Yrs
Hyderabad / Secunderabad
Snr. Spec. DDIT ISC Gov Control Assessment
3-5 Yrs
₹ 1 - 36.15L/yr (AmbitionBox estimate)
Hyderabad / Secunderabad
Spec. DDIT ISC Gov Control Assessment
2-5 Yrs
₹ 1.9 - 36.15L/yr (AmbitionBox estimate)
Hyderabad / Secunderabad
Share an Interview