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THE COMPANY

 PHASTAR is a multiple award-winning, data focused CRO specializing in providing statistics, programming, data management and data science to the pharmaceutical, biotechnology and medical device industries. With offices across the UK, US, Germany, Kenya, Australia, India, China and Japan, PHASTAR is the second largest specialized biometrics provider globally, and the largest in the UK. We have been accredited an ‘outstanding’ company to work for by Best Companies, for our commitment to employee engagement and workplace satisfaction.

Our unique approach to data analysis, “The PHASTAR Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

We offer flexible working arrangements, continuous learning and knowledge sharing opportunities, visibility with senior management, and the opportunity to contribute to company-wide process improvement initiatives.

Quality Assurance Manager

in UK - any office or home-based
Permanent
Start date: As soon as possible
Role and responsibilities

Manage Quality Assurance Services within PHASTAR; Manage and maintain oversight of Company Policies, Standard Operating Procedures and Work Instructions, devise and implement the internal annual audit programme, generate and manage the CAPA process, conduct internal audits and host external audits/regulatory inspections. Deliver appropriate GCP training to staff and ensure overall compliance with Clinical Trial Regulations and other applicable legislation.

Key responsibilities

  • Develop and implement Quality Assurance strategies
  • Generate and manage the internal audit programme
  • Independently conduct and report audits in accordance with the internal audit programme
  • Conduct Vendor Qualification Assessment Audits
  • Lead, manage and coordinate external audits and regulatory inspections
  • Maintaining tracking of audits conducted and report status
  • Developing and Managing CAPA system including periodic reporting to management teams on company-wide issues / trends
  • Manage the administration of procedural documents including the coordination, review and update; oversee the implementation of new procedures.
  • Review and QA approval of all procedural documents
  • Deliver appropriate GCP training to staff
  • Develop measures of quality (Key Performance Indices) and monitoring systems for these measures; develop an implementation plan, roll-out and train staff on their use.
  • Periodically report Quality metrics to PHASTAR Management
  • Ensure company-wide compliance to clinical trial legislation and ICH GCP and other applicable legislation
  • Provide advice and interpretation on new regulations and regulatory issues as they occur
  • As part of the quality assurance function, ensure all staff have complete and accurate training records; train staff on SOP compliance and maintenance of their training records
  • Maintain personal training record
  • Perform role in accordance with company policies and Standard Operating Procedures
  • Ensure an overall awareness of the company processes
  • Ensure high quality is fundamental to PHASTAR culture
  • Quantify results of Internal and External Audits for surveillance at project and corporate levels.
  • Maintain an awareness of regulations that apply to the company, and ensure PHASTAR processes match these regulations
  • Designated Data Protection Officer for PHASTAR – maintain awareness of applicable Data Protection legislation and updates
Experience
  • Educated to Bachelor's degree level or equivalent
  • Experience and training in regulatory affairs relating to clinical research and auditing
  • Familiarity with clinical trial regulations and Good Clinical Practice (GCP)
  • Computer literacy in Microsoft Windows, Microsoft Office (Word, Excel, PowerPoint)
  • Knowledge of Quality Management Systems

APPLY NOW

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques.

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