Job Title: GxP & Regulatory Intelligence   Job Description   - Develop, assess and deliver analytics on internal and external quality and regulatory intelligence through metrics, trends, performance report, news, alerts, and observations.  - Gather and analyze information on changes in laws, directives, regulations, guidance documents and consensus documents that are applicable to GxP regulated activities to provide an assessment of the 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.):   - Dashboard and metric reports   - Knowledge Management reports   - 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 timesheet is always kept updated for the responsible service area. Develop technical training content and impart training to the associates in the responsible service area.   Minimum requirements :  - Graduate/postgraduate 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

Hyderabad

Novartis - GxP & Regulatory Intelligence Role 

Novartis - GxP & Regulatory Intelligence Role  ,Job Description for Novartis - GxP & Regulatory Intelligence Role  in Novartis.com in  Hyderabad for (10-12) years of experience. Apply Now!

Job Description for Novartis - GxP & Regulatory Intelligence Role  in Novartis.com in  Hyderabad for (10-12) years of experience. Apply Now!