QA Officer

Highly Competitive
  1. Contract
  2. Good Clinical Practice (GCP)
  3. United Kingdom
Hurley, Berkshire
Posting date: 07 Feb 2019
QA.CM.21553_1549543915

An internationally renowned pharmaceutical company is advertising with ProClinical to recruit a QA Officer to their UK-based office. This company, which specialises in developing and producing medicines and vaccines for a wide range of therapeutic areas including oncology, cardiology and immunology, is looking for an exceptional individual to join their Berkshire team as QA Officer on a contract basis.

The QA will provide day-to-day assistance for commercial QA activities associated with running the site's QMS to support batch disposition activities. This will be done with relation to the company's Brexit preparations, and will involve the assignment and completion of tasks to meet internal standards and all associated international GMP/GDP requirements.

Job Responsibilities:

  • Maintaining quality systems; primarily the creation of QP declarations and associated electronic system changes to support Brexit preparations.
  • Supporting change management activities related to Brexit and site compliance activities.
  • Completing schedules records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP.
  • Supporting inspection readiness for BOH inspections and external vendor audits in relation to Brexit changes.
  • Collaborating with internal and external stakeholders to resolve quality issues, and ensure compliance to EU GMP standards.
  • Compiling and reviewing Product Quality review sets for completeness & compliance to EU GMP, company internal requirements, and regulatory dossier submissions.
  • Executing projects and supporting as required.

Skills and Requirements:

  • A Bachelor's degree in a related scientific discipline with relevant experience, preferably Biology, Chemistry, Pharmacy, or Life Sciences.
  • Demonstrable experience in pharmaceutical manufacturing, distribution, and control measures.
  • Demonstrable experience in Quality administration systems, with previous use of Trackwise QMS a desired bonus.
  • Experience in preparing or supporting QP declarations.
  • Experience in raising and management of change controls.
  • An ability to apply technical knowledge and understanding to make appropriate and timely risk-based decisions.
  • Demonstrably good planning and organisation skills.
  • Attention to detail and accuracy - able to follow verbal and written instructions (SOPs).
  • Quality and process orientation and mindset.
  • Possession of good verbal and written communication skills.
  • Proficiency with Microsoft Office is essential, whilst experience with electronic documentation control systems is an advantageous bonus.
  • Demonstrable experience with manufacturing novel dosage forms, along with secondary/outsourced packaging activities.
  • Experience with global manufacture, new product launches, and commercial supply chains.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

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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