Quality Systems Specialist

Quality Systems Specialist

Responsibilities include managing and coordinating the internal audit system, managing change control system, the process of vendor/service provider qualification and other activities related to QMS.
Contribution to the continuous improvement of the Quality Management System is required.

The Role
Management of Documentation Compliance Manager (DCM) system and archiving in relation to QMS systems
Provide reports to site in relation to Quality Management System (QMS) Documentation System as required.
Authoring of Standard Operating Procedures (SOP's) in relation to the Documentation System
Communicate with cross functional departments
Communication with the manufacturing sites in relation to QMS activities where appropriate
Management and coordination of CAPAs
Provide administration support in relation to Annual Product Reports
Management of GMP introductory and annual refresher training for all GWWO employees
Provide support to corporate and health authorities' site audits and response to audits' findings

Requirements
Excellent communication skills Competence in Microsoft packages specifically Word, Excel and PowerPoint
Ability to work proactively on own initiative
Excellent technical writing and analytical skills
Good organizational and time Management skills
Flexibility
Results orientated
Minimum of 2 years' experience in an Document Control role preferably in a Quality Control/Assurance setting and with experience in using Microsoft packages
Experience in managing/coordinating Change Controls, CAPAs
Degree in a science, pharmacy or related discipline.
Extensive knowledge and understanding of regulatory requirements and guidelines.
Experience in the pharmaceutical or related industry working under quality management systems

Desired Requirements
Experience of working in a team environment and participating in Project teams.
Experience in Documentum
Experience/certification in auditing