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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