Overview TekWissen Group is a workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation. Job Title: Quality Assurance Officer Location: Orega Marlow SL7 1YL Job Type: 5 Months Job Description 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. Organizational Relationships Reporting to line manager. Relationship with active EU Qualified Persons (QPs) performing certification Interactions with global Quality Assurance team, PGS manufacturing sites, EU testing labs and CMO support group (ESQ), as well as regulatory. 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. Training & Education Required 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 Possession of good verbal and written communication skills Ability to accept responsibility and be pro-active within defined limits Excellent system skills – Word and Excel essential, experience with electronic documentation control systems advantageous. Enthusiastic, positive individual driven to meet targets and standards High level of self- integrity and ethical conduct Training & Education Preferred Sterile injectable manufacture Manufacture of novel dosage forms Secondary / outsourced packaging activities Global manufacture and supply chains New product launches & commercial supply chain Prior Experience Required Experience from a quality-based job role Prior Experience Preferred 2-3 years in a GMP environment TekWissen Group is an equal opportunity employer supporting workforce diversity.