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:
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
Complete scheduled records and quality system tasks in a timely manner and in compliance with internal standards and EU GMP
To compile & review Product quality review sets for completeness & compliance to EU GMP, internal requirements, and regulatory dossier submissions
Support in internal audits
Participate in Quality Risk Management (QRM) assessments
Project execution and support as required.
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:
2-3 years in a GMP environment
Basic experience in pharmaceutical manufacturing, distribution, and control measures
Basic experience in Quality administered systems. Previous use of TrackWise® QMS beneficial.
Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
Able to demonstrate good planning and organisational skills
Attention to detail and accuracy – able to follow verbal and written instruction (SOP’s).
Quality and process orientation and mindset