Sunday, August 30, 2020

Covance Hiring Associate Manager, QA University/college degree BA/BS (life science preferred),or equivalent Apply Now


Covance Hiring Associate Manager, QA University/college degree BA/BS (life science preferred),or equivalent Apply Now


Job Overview:

Role is responsible for leading internal and external regional and global QA audits per Standard Operating Procedures and Master Audit Plan, assuring that audited systems, processes and their outcomes comply with applicable international and national regulations and guidelines, and fulfill client and Covance requirements. The position assures that audits assigned are completed on time and within budget, including audit reporting and CAPA follow up and closure.

 Essential Job Duties:

Lead audit teams in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards

Leads complex audits (e.g., directed, process, systems, office)
Provide suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is inadequate
Proactively identifies and leads process improvement activities / SOP updates
Hosts client audits and able to support regulatory inspections
Leads and/or participates in special projects
Represents Audit QA on project teams and other internal forums
Trains and mentors junior QA Audit staff / support on-boarding of new personnel

Education/Qualifications:
Required:

University/college degree BA/BS (life science preferred),or equivalent
Thorough knowledge, understanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs

Knowledge of the drug development process from the perspective of a contract research organization

Experience:

5 years CRO/Pharmaceutical experience

4 years in a GXP quality role, including at least 2 years in a GCP quality role required


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