Snr Spec Ii

6 days ago

Navi Mumbai, India Labcorp Full time

Bachelors/Masters/PhD degree in Medicine or Alternative medicine or Pharmaceutical science or Sciences

 5 plus years of overall work experience in the functional area with at least 2 years in Peer review/Quality review of any of the reports for global regulatory submissions and some experience in CAPAs and trending.

 Experience in generating quality metrics with trend analysis, authoring and coordinating Corrective and Preventive Action Reports

Keyskills:
Regulatory and Medical Writing, Quality Assurance

 Good understanding of various regulatory reports and ICH-GCP guidelines

Job description:
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables

 Ensure compliance of operations with governing regulatory requirements

 Create, maintain and assume accountability for a culture of high customer service

 Nurture and sustain an environment of continuous learning

 Contribute to building and growing the Practice through responsibilities related to Quality, Process Excellence and Training

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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