QA Auditor Iv

5 days ago

Bengaluru, India Labcorp Full time

**ssential Job Duties**
- Review of protocol, amendments and reports
- Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution
- Report on relevant quality metrics (for multiple topics/departments) and highlight trends
- Provide consultation to the operational team (e.g. as they revise/write controlled documents)
- Delivery of training in performance of audits (basic, intermediate audit activities)
- Work with operational management to support Quality topics and/or working on projects with QA team on other sites [showing development of collaboration skills]
- Contribute to local Quality initiatives and process improvement initiatives aimed at improving compliance and/or efficiency of the local QA organization
- Create and/or re-write QA SOPs based on findings from local quality initiatives.
- Organizing, Prioritizing and Managing all aspects of workload to meet business needs.
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties as assigned by management.

**Minimum Experience Required**
- 4 years in regulatory environment (experience in GXP roles, preferably GLP)
- ** Experience in Bio Analytical and Toxicokinetics audits preferred**:

- ** Should be okay working in 2nd shift working hours ie., 2:30 PM to 11:30 PM IST**:

- Experienced GxP auditor
- Experienced in process improvement
- Clear communication skills, including ability to provide clear feedback
- Able to clearly articulate processes in order to provide training
- Able to influence process improvement initiatives / offer solutions

**Recommended Education/Qualifications**
- A minimum of a Bachelor’s Degree in Life Sciences preferred (or equivalent Life Science experience)
- Experience may be substituted for education

**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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