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Senior Analyst-RCA/CAPA

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Your Role and Responsibilities

 

  • Handle end to end investigation of cases: Running a deep dive Root Cause Analysis by interviewing with multiple parties / stakeholders and drawing up a precise Corrective and Preventive Action Plan
  • Ensuing that the investigation process is completed within the given SLA with no fallouts
  • Serve as back up resource for other service owners as needed
  • Identify work process improvements and issue prevention


Required Technical and Professional Expertise

  • 10 – 12 years of overall experience with minimum of 7 – 9 years in End-End Audit / Issue Investigation, Quality and Compliance Controls (Pharmacovigilance domain will be preferred)
  • 7+ years in End-End Audit / Issue Investigation, Quality and Compliance Controls (Pharmacovigilance domain will be preferred)
  • Solid experience in conducting a deep dive investigation of audit failures, adverse events and non-compliance issues. Ability to draw up a comprehensive Corrective and Preventive Action Plan post the completion of the investigation process
  • Ability to manage multiple, diverse priorities under time pressure to meet key customer and procedural deadlines
  • Experience in running a Root Cause Analysis (RCA) and writing Corrective Action and Preventive Action (CAPA) plans: Minimum 2 projects
  • Proficient to manage multiple, diverse priorities under time pressure to meet key customer and procedural deadlines
  • Solid understanding to think through complex issues and situations and develop robust, well thought out solutions which meet the need of the business
  • Hands-on experience to effectively work with others – with internal customers and external suppliers and can positively influence others in problem solving and work process improvements
  • High degree of numeracy skills with meticulous attention to details


Preferred Technical and Professional Expertise

  • Graduate / Post-Graduate, Six Sigma: Black Belt Trained/Certified would be preferred
  • Ambitious individual who can work under their own direction towards agreed targets/goals and with creative approach to work
  • Intuitive individual with an ability to manage change and proven time management
  • Proven interpersonal skills while contributing to team effort by accomplishing related results as needed
  • Up-to-date technical knowledge by attending educational workshops, reviewing publications
Set alert for similar jobsSenior Analyst-RCA/CAPA role in Bangalore Urban, India
IBM Logo

Company

IBM

Job Posted

a year ago

Job Type

Full-time

WorkMode

On-site

Experience Level

8-12 Years

Category

Operations

Locations

Bangalore Urban, Karnataka, India

Qualification

Bachelor or Master

Applicants

Be an early applicant

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