GCP QA Manager

£60000 - £61000 per annum
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United Kingdom
London, England
Posting date: 13 Apr 2021

There is a new opportunity for a GCP Quality Manager at a large pharmaceutical organisation. You will be expected to assist in the implementation and maintenance of the Quality Management Systems in alignment with internal policies. This role is in London.

Job Responsibilities

  • Ensure compliance, drive consistency and support to improve and standardise the key operational activities with quality processes, standards and outcomes
  • Actively communicate and collaborate with functional areas to develop strong working relationships and provide the project quality support
  • Identify the potential challenges, propose solutions and advocate the proactive engagement
  • Support the audits and perform TMF quality control (focusing on completeness, accuracy, timeliness)
  • Create and maintain strong data alignment between internal and external sources of quality data
  • Identify compliance gaps and make recommendations for the quality programmes and continuous improvement initiatives
  • Create and review assigned Standard Operating Procedures (SOPs) in conjunction with the relevant regulations and standards
  • Carry out the assignments to the standards of high quality, efficiency, innovation, accuracy, integrity and safety in accordance with company and regulatory requirements

Skills and Requirements

  • At least 5 years' experience in the quality (auditing, quality oversight, QMS) working in Pharmaceutical, Biotechnology and/or CRO company
  • Bachelor's degree in Pharmaceutical or Science discipline as a minimum
  • Strong knowledge of QMS complexity with a practical understanding of global and local requirements and ICH GCP / GxP standards
  • Demonstrated ability to work independently and to drive the completion of tasks
  • Excellent communication, problem-solving, presentation and interpersonal skills

To Apply

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