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Change Control Manager

Company: Indotronix International Corporation
Location: Allentown
Posted on: March 28, 2020

Job Description:

Our company seeks a Technical Quality Specialists who will be part of the team that is responsible for the Deviation/Complaint Process and Change Control Process. This requires reviewing and approving all process deviations, distribution deviations, client complaints and assessing and approving all change controls. For Deviations/Complaints this requires strong analytical thinking skills, root cause analysis understanding and the ability to partner with colleagues to determine appropriate corrective and preventative actions. For Change Controls this requires being a facilitator of live Change Control Board and the ability to assess changes and their impact to quality/compliance. --Decision making needs to be based on strong quality/ compliance principals and appropriate GMP Regulations.-- Knowledge, Skills, Abilities A minimum of 5 years in the pharmaceutical/related regulated industry Experience with Investigation Management Quality Systems (e.g. deviation complaints). Experience with Change Control and CAPAs. Review and approve Deviation Investigations, Complaint Investigations, CAPA and CAPA Effectiveness Checks to ensure all information contained within is accurate per applicable reference documents and also complies with all SOPs and customer requirements.

Keywords: Indotronix International Corporation, Allentown , Change Control Manager, Executive , Allentown, Pennsylvania

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