Proclinical Staffing

Quality Executive

1 day left

Location
London, England
Salary
Negotiable
Posted
22 Feb 2021
Closes
08 Mar 2021
Ref
35816
Contact
Caleb Mensah
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Proclinical are seeking a Quality Executive to join a dynamic and talented team in London. The Quality Executive will provides technical and administrative quality support for the local operating company (LOC), for GxP, Commercial and R&D areas, to ensure adherence with relevant internal and external policies and procedures.

Job Responsibilities

  • Support GDP activities and the local quality release of batches of medicinal product for the UK & Ireland markets under the company Wholesale Distribution Authorisations
  • Support the change control, deviation, risk assessment and product complaints processes and assist with the performance of pre-qualification assessments and regular audits and evaluations of vendors as required by the business
  • All aspects related to the local QMS, including the writing and management of SOPs, the electronic quality systems and learning management systems
  • Assist with planning and performance of self-assessments and preparing for and supporting internal and external audits. Work with team members to compile periodic reports (monthly/annually) and escalate quality issues. Seek to protect patient safety and escalate non-compliances arising in the business as appropriate
  • Contribute to Quality Improvement Planning, Management Reviews, quality projects etc
  • Ensuring quality standards and deadlines are consistently met and documentation is completed accurately and to a high standard

Skills and Requirements

  • Undergraduate degree in a science, medical or technical field
  • Implementation and/or maintenance of ISO 13485 certificationManaging an e-Quality Management System (e-QMS)
  • Experience with writing concise and accurate reports
  • Working under pressure in a fast-paced environment
  • Creation of complex spreadsheets
  • Working with multiple parties to edit and refine complex word documents
  • Participating in internal and external audits
  • Self-motivated and able to work autonomously and problem solve in an ever-changing work environment

To Apply

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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