Description
This Pharmaceutical company is looking for a QA specialist to be responsible for managing document control, CAPA and internal audit processes. This person will also be responsible for providing QA support to product development and manufacturing.Responsibilities
* Coordinating CAPA process; perform review and closure of CAPA.
* Provides support to the change management program and document control activities.
* Coordinate internal audits.
* Track, trend, and report on assigned quality system metrics.
* Manage and maintain process deviation log and closures.
* Participate in the development of slides/data for Management Review.
* Conduct internal, external (supplier) and/or 3rd party audits.
* Participate in notified Body audits, regulatory inspections or 3rd party audits.
* Provide support for regulatory filings.
Requirements
* BS/BA in relevant discipline.
* Start-up environment experience is preferred.
* Minimum of 5 years experience in a Medical Device, Biotech, or Pharmaceutical organization.
* Thorough understanding of and ability to implement QSR regulations (21 CFR Part 820) and ISO 13485.
* Internal auditing experience.
* Strong verbal and written communication skills. Technical writing skill is preferred.
* Strong interpersonal skills.
To find out more about Real please visit www.realstaffing.com