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 : Expert - GxP & Regulatory Intelligence
Job Description:
• Gather and analyze information on changes in laws, directives, regulations, guidance documents and consensus documents that are applicable to GxP regulated activities to provide assessment of impact of these changes.
• Process targeted internal and external GxP and regulatory information from multiple sources and deliver the following as per agreed SLAs (timeliness, accuracy, quality, etc): o Dashboard and metric reports o Knowledge Management reports o Other ad-hoc trends and analysis
• Issue internal communication of GxP and regulatory changes to the right stakeholders through newsletters, presentations or other means as and when required.
• Maintain complete awareness of GxP relevant policies, guideline and regulations to assess dynamic regulatory landscape across the industry.
• Work with cross functional teams like ‘Data Analytics’ to improve the processes in relation to data mining, analysis and reporting.
• Hold and manage key accounts in workflow applications to ensure appropriate access is available to execute service deliverables.
• Provide active support during internal and external audits by collecting and presenting the requested data.
• Work together with Lead-Quality Operations and customers to ensure they are kept regularly informed of issues related to the service delivery and elaborate risk mitigation plans, as appropriate.
• Ensure the SOPs, working procedures, process maps, service dashboard, CAPA tracker, order management framework and time sheet is always kept updated for the responsible service area.
• Develop technical training content and impart training to the associates in the responsible service area.
Candidate Profile
Graduate / Post graduate in life sciences or pharmacy. MBA in pharmaceutical business will be an advantage. English Experience (10-12 years) in QA/Regulatory functions of a pharmaceutical company or Pharma KPO Previous experience in delivering GxP (worldwide GMP, GCP, GLP, PV & IT compliance) and regulatory intelligence is preferred Strong project management, analytical, investigative and presentation skills.
Additional Information:
Experience: 10-12 years
Location: Hyderabad
Education: M.Sc, M.Pharm, B.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Technical Operations
End Date: 30th October, 2017
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