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Covance CRS
,
Harrogate, North Yorkshire
QA Technical Specialist
Overview
Are you an experienced QA professional looking for your next challenge? Have you worked in the Pharmaceutical or Drug Development industry? Do you want to work for a company that helps build a healthier and safer world? As one of the world’s premier Contract Research Organisations, we provide research services for a multitude of organizations. We strive to make a difference to people’s everyday lives by bringing essential products to the market and as a QA Technical Specialist at Covance based at Harrogate, North Yorkshire, you will play an essential part in making this happen. The QA Technical Specialist is responsible for the development, implementation and improvement of methodologies aimed at meeting regulatory expectations Responsibilities will include: Representing QA on project teams aimed at validating new or upgraded computer system s and instrumentation Reviewing and approving key computer system validation deliverables Defining and managing inspection program(s) that are operated to assure the compliance of our computerized systems, instrumentation, and electronic records Leads a program of training relating to compliant Computer System Lifecycle Management and Data Integrity Assurance Guiding, advising, arbitrating and influencing the organization on a range of computer system compliance and data integrity matters Conducting specialist audits and audits of suppliers and service providers relating to the development and maintenance of computerized systems Providing subject matter expertise during hosted audits by clients and regulatory authorities and subsequent response and follow up of audit observations relating to computer system compliance and data integrity Represents Covance on external industry regulatory forums Bachelor degree (or equivalent) in Science or Technology related discipline Experience may be substituted for education in some circumstances Experience of working in a regulatory/QA role Experience as a Lead Auditor Demonstrable experience of successful client interaction External podium presentations at relevant regulatory meetings (preferred) Experience working in the Pharmaceutical or related Industry, preferably in a QA/compliance role and fully familiar with Good Practice Regulations (GLP, cGMPs, GCP) Working knowledge of regulatory agency guidelines relating to Computerized System Compliance/Data Integrity and Industry Standards, e.g. GAMP5 Ability to confidently interact with and influence staff at all levels, clients and regulatory authority representatives Proven organization, observation, and problem solving skills Skilled in written and verbal communication