A global healthcare leader, 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: Auditor / Sr. Auditor Pharmacovigilance
Job Description:
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement. Think what's possible. Novartis and its associated companies are always looking for talented employees globally. We are engaged in advance preparation for potential position openings. Submit your CV/resume now to join our talent pool for the position described below. Please note that you are not applying for a current vacancy, but are submitting your CV/resume for consideration for future, possible opportunities. We look forward to receiving your information.
Job Purpose
Conduct GCP/ PV Quality System audits at Sandoz own sites/entities and CROs 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 necessary assigned audits
• Keep track of audits of CROs etc. and follow-ups as and when required.
• Coordinate internally within affiliates and externally with CROs, Bio-analytical Labs, contractors
• Build strong technical skills with respect to GMPs and chosen pharmaceutical discipline - GCP, Pharmacovigilience and BA/BE
• Regional Specialist with respect to GCP. Provide guidance and support in respective area and support global audit group at times.
• Approve Corrective and Preventive Actions which are necessary due to audit findings
• Maintain audit data in a related data system (incl. reports and follow-up of audits)
• Support training sessions, audit planning and Risk Assessments (e.g. for Supplier Qualifica-tion)
• Assist in ensuring that Sandoz sites are prepared for Regulatory Agency Inspections through normal audit activities, “Mock Inspections”, training and other support activities
• Conduct effective “Due Diligence” activities of potential in-licensed products, acquisitions and partners as required
• 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 effective “For Cause” audits to investigate frequent Field Alerts, Recalls, Rejects and Complaints
• Keep Senior management aware of emerging Regulatory and GCP / PV 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
• Provide effective support during Regulatory Inspections as requested by QA.
• Willing to travel extensively in India, APAC region and globally, and on short term off site assignments for remediation projects based on business needs.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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Candidate Profile
• Education: Graduate in Pharmacy, Chemistry, Microbiology, Biochemistry or another related science; additional knowledge in Quality Assurance/Compliance and Auditing
• Languages: English fluent in speaking and writing, 2nd language desirable
• Experience: min. 8-10 years’ experience in the pharmaceutical or biopharmaceutical industry, e.g. in Pharma Production, Quality Assurance, Quality Control, Development, Audit experi-ence desirable
• Prior Auditing experience desirable
• Good knowledge of Regulatory Agency Inspection Requirements, e.g. FDA
• Strong analytical skills
• Very good communication and organizational skills
Additional Information:
Experience: 8-10 years
Location: Mumbai
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Division: Pharma
Job Type: Full Time
Employment Type: Regular
Job ID: 168900BR
End Date: 25th July, 2015
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