A QA Officer is required for a global Pharmaceutical company who have a site based near Marlow in Buckinghamshire. Reporting to the Quality Manager on site, the QA Officer will provide day-to-day assistance for commercial QA activities associated with effective running of the site QMS supporting batch release. The QA Officer will ensure assigned tasks are performed in a timely manner to meet internal standards and all associated international GMP/GDP requirements.
The opportunity for the QA Officer is available as an initial 5-month contract with likelihood of extension. The role will also offer a hybrid working pattern and a competitive hourly rate.
The key responsibilities for the QA Officer:
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To assist in maintenance of quality systems including deviations/ exception reporting, change control, supply agreements, document control, quality metrics reporting, training as determined by the QA Manager
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Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP
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To compile & review Product quality review sets for completeness & compliance to EU GMP, internal requirements, and regulatory dossier submissions
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Support in internal audits
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Participate in Quality Risk Management (QRM) assessments
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Project execution and support as required.
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Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team
The experience required to be the successful candidate:
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2-3 years in a GMP environment
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Basic experience in pharmaceutical manufacturing, distribution, and control measures
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Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.
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Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
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Able to demonstrate good planning and organisational skills
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Attention to detail and accuracy – able to follow verbal and written instruction (SOP’s).
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Quality and process orientation and mindset