Negotiable
Undetermined
Onsite
Marlow, England, United Kingdom
Quality Assurance Officer (Compliance) - Marlow (Hybrid) - 5 Months contract - upto 19.50 per hour UmbrellaOverview:Reporting to a Quality Manager, 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.Primary Duties: 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, client 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.Experience required: Basic experience in pharmaceutical manufacturing, distribution, and control measures. 2-3 years in a GMP environment. Basic experience in Quality administered systems. Previous use of TrackWise QMS beneficial. Attention to detail and accuracy able to follow verbal and written instruction (SOP s). Excellent system skills Word and Excel essential, experience with electronic documentation control systems advantageous.Experience preferred: Sterile injectable manufacture Manufacture of novel dosage forms Secondary / outsourced packaging activities Global manufacture and supply chains New product launches & commercial supply chain
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