Your Role and ResponsibilitiesAs a Senior Analyst, you are responsible for handling clients across industries within the quality space. You will be responsible to manage complete investigation process related to quality and compliance controls.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
- Conduct quality reviews as needed (Involves reviewing documentation against a checklist from a quality plan)
Required Technical and Professional Expertise
- 5 – 7 years in End-to-End Audit / Issue Investigation, Quality and Compliance Controls (Pharmacovigilance domain 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.
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.