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: QA Auditor Associate
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Job Description:
Job Purpose
Conducts audits of Novartis OTC 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; as applicable.
Major Accountabilities
Plans, schedules, coordinates, and conducts audits
Evaluates and communicates compliance of audited site / operation to the Auditee as well as No-vartis Management.
Reviews and approves, in collaboration with the responsible Quality units, proposed correc-tive/preventative action plans
Verifies implementation and effectiveness of agreed corrective/preventative actions
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Reports and trends audit observations
Completes Lessons Learned and shares Best Practices resulting from audits/inspections
Author and review Standard Operating Procedures, as needed
Author Quality Agreements, as needed
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Candidate Profile:
Education: Bachelor of Science Degree in Chemistry, Pharmacy, Biology, or Related Science.
Languages: Good English skills required. Excellent fluency in local lanugauge, communication & negotiation skills (oral and verbal). Excellent techncial writing and oral communication skills are required.
Experience:
• Minimum of 5 years industry experience, including a minimum of 3 years of auditing experience (defined as ≥10 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 60-70%
• Good interpersonal and leadership skills
• Excellent knowledge of computer systems; i.e. Microsoft Word, Excel, PowerPoint, & Visio
Additional Information:
Experience: 5-6 years
Location: Thane
Education: B.Pharm, B.Sc-Chemistry, Biology
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 73530BR
End Date: 18th Sept., 2011
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