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: Manager - Compliance & Auditing
Job Description
Conducts audits of Novartis operational sites and Global Third Parties for the purpose of identifying any non-compliance to the Novartis Quality Manual, National / International GxP requirements, and Local Standard Operating Procedures; Conducts surveillance, due diligence, for-cause audits, Mock PAIs, as well as Quality System verification audits; Manages inspections by Health Authorities, as applicable
Major Accountabilities
• Plans, schedules, coordinates, and conducts audits
• Evaluates and communicates compliance of audited site / operation to the Auditee as well as Novartis Management.
• Reviews and approves, in collaboration with the responsible Quality units, proposed corrective/preventative action plans
• Verifies implementation and effectiveness of agreed corrective/preventative actions
• Analyzes, Reports and trends audit observations
• Completes Lessons Learned and shares Best Practices resulting from audits/inspections
• Provides training to Quality organization in audit fundamentals
• Author and review Standard Operating Procedures, as needed
• Author Quality Agreements, as needed
Minimum requirements
Education :
Bachelor of Science Degree in Chemistry, Pharmacy, Biology, or Related Science. Advanced Degree preferred.
Experience:
Minimum of 10 years industry experience, including a minimum of 6 years full-time auditing experience (defined as ≥15 audits/year, or equivalent). Industry: Pharmaceutical industry related to Quality Assurance, Quality Control, Drug Regulatory Affairs, Manufacturing Operations, or equivalent.
Working knowledge of regulatory agency requirements; US FDA, EMEA< MHRA, WHO, ANVISA, US DEA, ICH, INVIMA, ISO, MDD, as well as others is required.
Experience in international & multidisciplinary environments
Willing to travel worldwide; sometimes at short notice: travel time 75-85 %
Additional Information:
Job ID: 122398BR
Experience: Minimum 10 years
Location: Thane
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 10th July, 2013
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