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Quality Systems Associate

Employer
Hobson Prior
Location
England, Hertfordshire, Stevenage
Salary
GBP33000 - GBP36000 per annum
Start date
17 Jan 2022
Closing date
14 Feb 2022

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Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Hobson Prior are looking for a Quality Systems Associate to join a pharmaceutical organisation on a permanent basis located in Stevenage. Our client is focused on creating new drugs to treat rare CNS disorders.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

  • Maintain high level of knowledge and expertise in GCP, Quality Assurance and Regulatory compliance across multiple territories.
  • In consultation with our external QA consultant, management and maintenance of the SOP and other QA documentation processes.
  • Champion the evolution and oversight of the Quality Management System throughout the company, providing input to ensure it remains relevant for the company's business.
  • Contribute to the oversight of the company's vendors according to SOPs and maintain vendor oversight folders.
  • Act as the primary contact for Regulatory Authorities during inspections.
  • Act as Company Archivist.
  • Set-up and actively maintain folder structures associated with product development and clinical studies on an ongoing basis (MPD/TMF Sponsor files).
  • Liaise with internal and external clinical study team members (e.g. consultants, clinical Vendors) to ensure robust and timely preparation, filing, and archiving of clinical documentation according to SOPs.
  • Support general project management activities including but not limited to setting up trial specific meetings, taking meeting minutes/providing agendas to the clinical team, tracking screening/enrolment across all sites, and maintaining study status trackers.
  • Some requirements to travel to external contractor's and investigational sites to review TMF files.
  • Opportunity to attend external audits with consultant auditors.

Key Skills:

  • Excellent attention to detail, highly organised and able to effectively prioritise tasks.
  • Team player with good interpersonal skills, and confidence to interact with all levels of the organisation.
  • Self-motivated and able to work well independently.

Requirements:

  • Previous experience working with SOP's.
  • Previous experience of set up and TMF management.
  • Previous clinical trial admin experience.
  • Experience using Excel, Word, PowerPoint and Outlook.
  • Experience working on US based clinical trials and/or with regulatory submissions is not a requirement but would be a bonus.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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