12 March, 2022
About the job
Role / Job Title: Compliance Excellence
Domain: Life Science
Preferred Educational Qualification for the role: Bachelor’s degree Science. College/University degree – A minimum of Bachelor’s Degree in life science (Bachelor of Science/Bachelor of Pharmacy/Master of Pharmacy/other Life Science graduates) with a minimum 4-5 years of experience in clinical trials/operations or allied fields.
Work Location: Mumbai/Bangalore
Preferred experience for the role:
Good working knowledge of the global pharmaceutical/Clinical Practice regulations (ICH/ GCP etc.).
Active involvement in CAPA management activities within the team.
Associate should have a fair understanding of the purpose, process, the people involved in CAPA management across domain, system, operations and compliance.
Preferably must have faced Internal / Client audit.
Knowledge of TrackWise shall be an added advantage.
Interpersonal and professional skills to interact at all levels including senior executives, contractors and colleagues.
Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions.
Highly organized, with exceptional good analytical and reasoning capability, ability to multi-task and prioritize.
Thorough understanding of quality systems
1.Perform data aggregation and verification for existing open GMP / GCP / CSV CAPAs (both from internal Audits and Regulatory Inspections) and deviations, and also perform analysis of the CAPAs
a. Analysis shall involve aggregation and prioritization of the existing open records based on parameters like the criticality of the findings, regulatory impact, ageing, systemic or local issues, repeat observations, etc.
b. Perform trend analysis and suggest pre-emptive actions wherever applicable.
2. Perform data entry in TrackWise, follow up with respective stakeholders for timely and effective closure of assigned CAPAs / findings, and deviations, by performing all the required processes including the Root Cause Analysis (RCA), writing Corrective and Preventive actions; tracking and monitoring CAPAs with the assigned stakeholders, and ensuring an effectiveness check, where applicable.
3. Responsible for TrackWise entries of the mock inspection report findings.
Interested candidates can share their CV to email@example.com