Senior QA Specialist

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In this key role, the senior QA specialist must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with departments such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.Principal ResponsibilitiesProvide quality and cGMP input and oversight for all start-up project activities through commercial readiness for the BDS facilityReview and approval technical support documentation. (Examples include cleaning, process, method validation).Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.Responsible for review and approval of Master Batch Records in accordance with internal procedures and GMP principles.Responsible for review and approval of Master electronic Batch Record recipes in accordance with internal procedures and GMP principlesProvide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control ProgramsProvide quality oversight of calibration and preventative maintenance criticality assessments as required.Author, review and approve Quality Related Procedures as requiredSupport the Vendor Management Program.Support the Raw Material Qualification Program.Develop and report quality metrics QualificationsMinimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibilitySound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirementsDemonstrated success records in auditing and improvement processesleadership and interpersonal influencing skillsverbal and written communication skills with well-structured communication and presentation ability to various audience levelsEfficient in SAP, EMDS, MES and Trackwise.Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales