Overview

Quality Compliance Specialist

Ware, Stevenage

The company

Our client provides general facilities maintenance and construction project work to the commercial sector as well as facilities maintenance services to the Public Sector and Private Sector at multiple sites.

The role

Working within a small Compliance team on the client’s pharmaceutical site, you will ensure the delivery of compliant engineering services which support the manufacturing utilities.

Reviews company and subcontractor/ vendor operations which support the engineering facilities to the life science areas, and documentation for compliance with local and global regulatory standards. Must have a good understanding of Quality Systems and Compliance within a regulated engineering or manufacturing environment. Serves as a Quality Assurance (QA) resource to support engineering quality documentation and other compliance related activities. Helps to coordinate implementation of best practices tasks across departments, sites and regions as directed.

  • Working within a small Quality and Compliance team on the client’s pharmaceutical site, you will ensure these aspects of the engineering service provided meet the client’s procedural requirements.
  • Support the compliance team in implementation of business requirements around GxP needs.
  • Provide support for issues related to third party contractors, equipment, systems or utilities having significant risk to the client operations.
  • Conduct appropriate compliance internal audits on a regular and ad hoc basis.
  • Support Client & Regulatory assessments by planning and preparation, and facing the auditor as requested.
  • Control, monitor and complete where appropriate, audit actions to ensure actions are closed out as required
  • Assist in training sessions to ensure Engineering teams have an understanding of quality requirements and procedures.
  • Ensure monthly reports/KPIs commitments are published and submitted to the Line Manager.
  • Support the Operations team in delivering the required compliance needs in regulated areas and with the day to day site management when requested.
  • Initiate engineering change controls, action, monitor and track to closure.
  • Represent the quality compliance function at meetings and presentations.

Could this be for you?

  • Degree similar in Engineering or manufacturing within pharmaceutical/healthcare industry, or equivalent related work experience within a regulated manufacturing or processing environment
  • 7+ years working in a regulated Engineering Quality, facilities maintenance, or a manufacturing operations organization
  • Specialized training or certification in quality assurance audits preferred.
  • Ability to identify and act on Compliance Risks within responsible area.
  • Experience in review of audit related documentation.
  • Full UK driving license.
  • Must have demonstrated experience in a safe, team-based, high-performance, quality-driven environment.

Why apply?

  • FTC
  • £40-45k

Please contact Kirsty to discuss further

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