Sr. Executive - Remediation - Investigations & Change Management
Hospira Healthcare India PVT LTD
5 - 7 yrs
Mumbai
Job Description
- Support Investigation Manager with the execution of remediation work plan which include but limited to:
Assist cross functional investigation team (e.g. Production, Quality, and Regulatory) with high risk / complex investigation by providing guidance and qualify oversight (e.g. risk and impact assessment, hypothesis development and testing, root cause analysis, scientific / technical writing, following SOP)
Reducing compliance risk of new and existing high risk investigations records and associated CAPA records for key elements such as impact / risk assessment, scientific approach, sufficient supporting data & justification, proper and effective use of investigation tools
Assist Investigation Managers program for improving sites investigation process and capability, activities include but not limited to:
Improving procedures for simplification, effective guidance, and ease of execution
Improve cross functional investigation team members capability for executing and documenting investigation (e.g. hypothesis development and testing, root cause analysis, scientific / technical writing)
Train investigation team on effective use of investigational and quality improvement tools and techniques (e.g. DMAIC, Fishbone diagram, 5 Whys)
Provide regular update to Investigation Manager with progress reports, metrics related to remediation activities program for update to site leadership team and executive steering committee
Timely escalation to Investigation Manager of any competing priorities and risk to ensure timely completion of remediation work plan activities Along with Investigation Manager, function as the sites subject matter expert on investigation and advise site on leading practices for conducting effective investigation to support continuous improvement
Posts
