CQV Technical Lead

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Company: Katalyst HealthCares and Life Sciences

Location: Indianapolis, IN 46227

Description:

Responsibilities:

Coordination and maintenance of CQV.
Review of Protocols.
Execution of approved protocols including generating/closure of all protocol deficiencies (deviation).
Generation of maintenance plans within CMMS.
Generation of Qualification summary report i.e. Summary Report, Trace Matrix.
Generation of handover release form.

Requirements:

Document revision and Approval Follow-up for URS, TQPAS.
Require Onsite resource assigned at the site.
Trained on GMP curricula to support CQV activities.
Create New Documents and Support review and approval of the following documents.
Execution of approved protocols including generating/closure of all protocol deficiencies.