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QA Document Coordinator

Job Reference:
586874
Recruiter Name:
Parkside Recruitment
Job Type:
Administration
Salary:
£28,000 to £32,000 per annum
Locations:
England
Contract Type:
Contract
Date Posted:
11/04/2018

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Our client, a leader in their industry, are seeking an experience QA Coordinator to join their fast paced team. The role will be to support the continuing development and upkeep of a comprehensive Quality Management System, maintaining existing QA systems, ensuring adherence to these systems and ensuring that Standard Operating Procedures (SOP's) are in line with applicable global, regional and local guidelines.

Major accountabilities

Document Management

  • Support development and on-going use of an electronic document management system (EDMS) and associated on-line training system
  • Act as primary contact for support/queries for SOP Management Systems
  • Maintain systems such that local and regional SOP's are managed in both hard copy and electronic format
  • Support review of SOPs in the area of QA & Technical Operations responsibilities to ensure compliance with regulatory requirements and guidance documents and maintain global harmonisation
  • Maintain SOP documentation archiving systems

Quality Assurance

  • Provide input to QA & Technical Operations for decisions related to processes with relevance for GxP compliance
  • Act as "super user" for SOP management system. Liaise with other departments for technical and administrator support for this system.
  • Provide administrative support to the deviations system by assigning deviation form and corrective action form numbers and archiving of completed documents
  • Provide administrative support to the change control system by assigning change control numbers, circulating change controls for review and approval and archiving of change controls
  • Maintenance and filing of contractor related documentation
  • Prepare and maintain other types of GxP documentation such as packaging specifications, audit schedules and supplier approval forms
  • Support identification of process gaps and deficiencies in local and regional quality systems, liaise and collaborate continuously with other departments
  • Provide administrative support to QA & Technical Operations meetings and to other quality systems, including taking minutes, as appropriate
  • Support competent authority inspections as applicable

Training

  • Administration of training files including training file audits
  • Maintenance of a training curriculum for SOP's
  • Support local and regional training procedures to satisfy compliance requirements
  • Take primary responsibility for creating training tasks for assigning training in the on-line training management system
  • Preparation of training records for new starters
  • Arrange QA documentation training as required
  • Assist in the preparation of training materials and associated documentation for QA training sessions

Key Requirements

  • Strong relevant QA admin or coordination experience
  • Good communication skills. Very good written and spoken English.
  • Ability/flexibility to work on a broad range of activities providing hands-on operational support.
  • Teamwork/ownership. Desire to play a key role in the management of the business, taking ownership of issues and driving initiatives to build a strong business.

Please apply via the website with your most recent CV and a short covering note detailing your interest in the role.

Please also note this position is not to start until the new year.

Parkside Recruitment Ltd is acting as an Employment Business in relation to this vacancy. Parkside Recruitment is an Equal Opportunities Employer.

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