Sr. QA Auditor - UK/EU(SP36HM161)

Core Accountabilities: The Sr. QA Auditor is responsible through the promotion of a quality driven culture through the conduct of audits for the CRO, The senior specialist will ensure the organization maintains an appropriate level of regulatory compliance while facilitating the achievement of project deliverables and timelines.This role can be remote anywhere in the UK or EU. Principal Responsibilities:Performing AuditsVerify the organization meets the relevant internal standards, good practices and regulatory requirements in regard to policies, procedures and systems by performing internal audits.Perform Investigator Site Audits to ensure regulatory compliance to the appropriate Sponsor protocol and regulatory requirementsPerform audits of vendors to ensure compliance with regulatory standards and sponsor requirementsPerform study based audits per requirements of internal procedures and sponsor requirementsHost Sponsor/Contractor audits and Regulatory InspectionsEnsure the latest version of Sponsor SOPs, forms and templates appear on the electronic database.Act as both a tema and lead auditor as required by Quality Assurance Corrective and Preventative Action ItemsRecord CAPAs into QMS system trackersTrack and follow CAPAs for internal and external auditsMonitor CAPA responses are timely and responses accurately address issues noted in audits or identified through general CRO processesPerform CAPA effectiveness checks for internal corrections Policies and ProceduresAct as a quality reviewer ensuring global SOPS meet regulatory requirementsIdentify areas of process improvement through the execution of internal audits Regulatory Intelligence and ConsultancyAct as a consultant  on company quality issues, providing support to operations to ensure quality deliverablesTroubleshoot issues identified by management and lead directed and for cause audits when requestedContribute to team discussions by providing compliance consultancy for internal and sponsor projectsCommunicate and perform GAPA analysis due to changes or proposed changes to new and proposed regulations and guidances. Additional The above job description in no way states or implies these duties are the only duties performed by this employee.  The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company. Essential Work Experience, Qualifications and Knowledge:2-4 years GCP Quality Assurance auditing experience in a pharmaceutical organization or CRO Desirable Work Experience, Qualifications and Knowledge:Previous pharmaceutical or CRO QA auditing experienceDegree in Life Sciences or related disciplineExperience in Microsoft Word, Excel and PowerPoint.Excellent organisational skills.Good communication skills.Sound Knowledge of relevant GCP related guidelines and regulationsAbility to learn new systems and pass knowledge onto others, either verbally or by written instruction. Cmed Core Values and Guiding Principles:All Cmed employees are required to exhibit and demonstrate the Cmed ‘Core Values’.Client focus: Satisfaction and SolutionsDependability: Competence and QualityTrustworthy: Open and HonestInnovative: ApproachesWinners: Win-Win All Cmed employees are required to follow Cmed’s Guiding Principles:We care about our customers, but are not afraid to say no or disagreeWe only take on projects within our abilities to perform wellWe always aim to do the right thing and approach every situation with good intentionsWe pursue responsible profit and responsible growth, and spend money sensibly, as if our ownWe believe organisation, management, governance and control are positive, but bureaucracy and micro-management are negativeWe love common senseWe are the enemy of mediocrityWe have a hunger for innovation and a thirst for ideas We show integrity and deal with mistakesWe acknowledge and value the contribution of othersWe always strive to build an atmosphere that is positive, professional and funWe are one Cmed Team Attributes Include: Planning and Organisational Skills: Communication and Teamwork:Excellent written and verbal communication skills.The ability to make effective presentations.Demonstrated ability to manage and leadDemonstrated ability to mobilize and motivate teams to ensure delivery in excellence. People Leadership:Demonstrated ability to manage staff, providing guidance and overall professional development.An ability to delegate tasks appropriately.Approaches work with a professional, positive, and enthusiastic attitude. TechnicalDemonstrated experience with performance appraisal process, performance improvement, and resource planning.Experience in personnel, financial and operational management. OtherUp to 20% travel

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Date Posted:

Posted 1 week ago

Expiration Date:



Haywards Heath



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