Delivery Excellence - Life Science - M Level
Delivery Excellence - Life Science - M Level
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Experience range : 8-11 years
JOB DESCRIPTION:
Responsibilities
• Assessment Planning Preparation Execution Finding classification Reporting Finding verification and Closure
• Own and conduct various types of internal assessments
• Own and support external certifications for ISO audits and client audits
• Assess identify and provide Early Risk Alerts to delivery and leadership teams provide recommendations to mitigate the same avoiding customer escalations.
• Develop strategic initiatives to maintain and improve the assessment function which in turn adds value to the business.
• Articulate FRS log the same in the DELite tool for the assessments done within the SLA period
• Review the assessment findings of junior assessors /reportees and mentor /upskill them
• Verify the CAPA taken by the team objectively and ensure closure of findings within the SLA and ensure findings don’t become aged and obsolete
• Facilitate the project teams Compliance teams and DE Enable teams for the external audits and customer audits by planning and executing mock assessments.
• Collaborate and work as a team wherever applicable
• Train/Mentor new hires
• Participate in knowledge sharing sessions
• Ensure Audit readiness and execute relevant responsibilities during external audits/inspections
• Meeting Assessment service levels and ensure quality of Assessment findings
Educational Qualification
• Education: Science/Engineering Graduate/Post- Graduate
• Work Experience: Overall experience of 8-10 years and relevant experience 5 - 8 years
Essential Skills Domain Knowledge
• Basic knowledge on Pharma Value Chain Process 21 CFR Part 11 21 CFR Part 820 & Computer System Validation.
• Good knowledge of ICH-GCP Good Pharmacovigilance Practice ISO 9001:2015 ISO 13485 and other applicable governing regulations in Life Science domain.
• Good knowledge of standards / accreditations like: ISO CMMI (Svc) eSCM COPC URAC etc considered as added advantage.
• Trained in lean or six sigma concepts (recommended).
• In-depth understanding of end-to-end clinical trial documentation and compliance requirements at each stage gates.
• Basic Tools knowledge preferable such as EDC EMR IVRS IRT (clinical study).
Employment Type
Full Time
