Upload Button Icon Add office photos
filter salaries All Filters

260 Novartis Jobs

Expert GMP Auditor

15-16 years

Mumbai

1 vacancy

Expert GMP Auditor

Novartis

posted 3mon ago

Job Role Insights

Flexible timing

Job Description

Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
Align strategic direction with senior leaders of Novartis and help establish programs to implement. Provide expert consultation to Novartis business units through risk based assessments. Act as SME for assigned areas of responsibility. Represent the company in external interactions with Health Authorities and industry groups.

Key Responsibilities:
  • Contribute to establishing the strategic direction of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
  • Plan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
  • For this expert role, the leader in this position is able to audit complex and high-risk sites and activities. The leader in this position is considered an expert and SME in one or more manufacturing areas, such as sterile manufacturing, combination products, biologics, etc.
  • Provide technical guidance, mentoring, and training on audit activities.
  • Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
  • Prepare audit reports according to NVS requirements and timelines.
  • Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
  • Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
  • Act as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed.
  • Review and advise on relevant policies and procedures.
  • Mentor junior GMP staff as required. Ability to perform training for non-certified and junior GMP staff.
  • Maintain current, expert knowledge of regulations and elaborate best practices auditing guideline (when applicable). Support development/training of GMP auditors.
  • Support HA commitments and global commitments/initiatives as an outcome of inspection findings.
Essential Requirements:
  • At least 15 years broad experience in Pharmaceutical or Medical Device Industry.
  • The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
  • At least 3+ years auditing experience, and excellent knowledge of regulatory requirements. Willingness to travel approximately 60% of the time.
  • Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
  • Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
  • Excellent interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers. The Associate must be able to effectively represent the department both internally and externally.
  • Sound and practical judgement in the interpretation and application of regulations and standards
  • Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
  • Excellent leadership and facilitation skills
Desirable Requirements:
  • Degree in Chemistry, Pharmacy, Biology, Engineering or another related science
  • Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is preferred.

Employment Type: Full Time, Permanent

Read full job description

Prepare for Auditor roles with real interview advice

People are getting interviews at Novartis through

(based on 98 Novartis interviews)
Job Portal
Referral
Company Website
Campus Placement
Recruitment Consultant
Walkin
35%
20%
13%
9%
3%
2%
18% candidates got the interview through other sources.
High Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.

What people at Novartis are saying

What Novartis employees are saying about work life

based on 1.5k employees
89%
76%
54%
98%
Flexible timing
Monday to Friday
No travel
Day Shift
View more insights

Novartis Benefits

Health Insurance
Work From Home
Free Transport
Cafeteria
Soft Skill Training
Gymnasium +6 more
View more benefits

Compare Novartis with

GlaxoSmithKline Pharmaceuticals

4.1
Compare

Sun Pharmaceutical Industries

4.1
Compare

Cipla

4.1
Compare

Dr. Reddy's

4.1
Compare

Pfizer

4.0
Compare

Biocon Limited

3.9
Compare

Aurobindo Pharma

4.0
Compare

Lupin

4.2
Compare

Zydus Lifesciences

4.2
Compare

Torrent Pharmaceuticals

3.9
Compare

Viatris

4.2
Compare

Abbott

4.2
Compare

Johnson & Johnson

4.1
Compare

Sanofi

4.3
Compare

Fresenius Kabi

4.2
Compare

Novo Nordisk

4.1
Compare

Piramal Pharma

4.0
Compare

Teva Pharmaceuticals

4.0
Compare

AstraZeneca

4.2
Compare

Bayer

4.1
Compare

Similar Jobs for you

Quality Auditor at Novartis Healthcare Pvt. Ltd.

Mumbai

15-16 Yrs

Not Disclosed

Auditor at Sandoz

Mumbai

15-17 Yrs

Not Disclosed

Quality Auditor at Sandoz

Mumbai

15-20 Yrs

Not Disclosed

Quality Operator at Novartis Healthcare Pvt. Ltd.

Hyderabad / Secunderabad

10-12 Yrs

Not Disclosed

Auditor at Novartis Healthcare Pvt. Ltd.

Mumbai

15-16 Yrs

Not Disclosed

Investigator at SUN PHARMA

Kalol

12-20 Yrs

Not Disclosed

Production Manager at SUN PHARMA

Kolkata, Mumbai + 5

12-20 Yrs

Not Disclosed

Investigator at SUN PHARMA

Kalol

10-16 Yrs

Not Disclosed

Senior Executive Quality Assurance at Siora Surgicals

Sonipat

8-13 Yrs

Not Disclosed

Product Owner at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

10-13 Yrs

Not Disclosed

Novartis Mumbai Office Location

View all
Mumbai Office
Novartis India Ltd, Sandoz House, Shivsagar Estate, Dr Annie Besant Road, Worli Mumbai
Maharashtra 400018

Expert GMP Auditor

15-16 Yrs

Mumbai

Pharmacy, Microbiology, German +6 more

3mon ago·via naukri.com

Global QMS Manager

6-9 Yrs

Hyderabad / Secunderabad

Hospital Administration, Project Management, Procurement +9 more

8hr ago·via naukri.com

Senior Expert Data Science

4-10 Yrs

Hyderabad / Secunderabad

Pharmacy, Data Analysis, Pharmaceutics +7 more

8hr ago·via naukri.com

External Operations Manager

3-4 Yrs

Hyderabad / Secunderabad

Supply Chain Management, Project Management, Operations +7 more

8hr ago·via naukri.com

Senior Life Cycle Program Manager

5-10 Yrs

Hyderabad / Secunderabad

Pharmacy, Supply Chain Management, Project Management +3 more

8hr ago·via naukri.com

Specialist - MS&T

5-10 Yrs

Hyderabad / Secunderabad

Pharmacy, Clinical Data Management, Packaging +5 more

8hr ago·via naukri.com

C&Q Engineer- Executive

5-8 Yrs

Hyderabad / Secunderabad

Pharmacy, Legal Advisory, Project Management +7 more

8hr ago·via naukri.com

Sr. Specialist QA Engineer(Salesforce, AWS and Automation)

8-13 Yrs

Hyderabad / Secunderabad

Salesforce, AWS, Spanish +5 more

8hr ago·via naukri.com

Senior eCompliance Manager

10-20 Yrs

Hyderabad / Secunderabad

Pharmacy, Software Configuration Management, Information Technology +6 more

1d ago·via naukri.com

Data Engineering Manager - Data Services

8-10 Yrs

Hyderabad / Secunderabad

Pharmacy, Python, Supply Chain Management +7 more

1d ago·via naukri.com