Job for QA Auditor at Novartis

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : QA Auditor

Job Description
Position Purpose:
Conduct GMP and Quality System audits at Novartis Technical Operation’s (NTO’s) Key Third Party contractors or suppliers as lead or supportive auditor to monitor that all aspects of the operational business comply with GXP legal and Regulatory Requirements and the Novartis Group Quality Manual and Policies.

Major Accountabilities
• Conduct all assigned GMP audits
• Approve Corrective and Preventive Actions which are necessary due to audit findings
• Evaluate and trend audit and inspection findings
• Maintain audit data in a related data system (incl. reports and follow-up of audits)
• Exploring potential data integrity concerns during audit.
• Identify compliance risks and develop sound rational for observations against current regulatory requirement and standards.
• Support training sessions, audit planning and Risk Assessments (e.g. for Supplier Qualifica-tion)
• Identify and Report Critical and Major Quality and Compliance Risks and Gaps during audit activities
• Ensure effective follow-up audits of sites with significant quality and compliance issues
• Conduct Pre-Qualification audits of potential new Suppliers and Contractors
• Keep Senior management aware of emerging Regulatory and GMP trends to help avoid Compliance Risks
• Assist in the establishment and maintenance of effective KPIs to help identify key quality and compliance trends and issues
• Willing to travel extensively in India and APAC region, and on short term off site as-signments for remediation projects based on business needs

Candidate Profile :
Graduate in Pharmacy, Chemistry, Microbiology, Biochemistry or another related science; additional knowledge in Quality Assurance/Compliance and Auditing English fluent in speaking and writing, 2nd language desirable 8-10 years’ experience in the pharmaceutical or biopharmaceutical industry, e.g. in Pharma Production, Quality Assurance, Quality Control, Development, Audit experience desirabl.

Additional Information:
Location: Navi Mumbai
Education: B.Sc, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Quality
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 214417BR
End Date: 25^th October, 2017