Quality Associate - Good Manufacturing Practice(GMP)

Job Overview:Areyou interested in starting a career as a trainee Quality Assuranceprofessional?  Do you want to work in thePharmaceutical/Drug Developmentindustry? Do you want to work for a company thathelps build a healthier and saferworld? As one of the world’s premier Contract ResearchOrganisations, we provide research services for a multitude oforganisations. We strive to make a difference to people’s everyday livesby bringing essential products to the market and as a QualityAssociate at Covance by Labcorp, based at Harrogate, NorthYorkshire, you will play an essential part in making thishappen. The Quality Associate is responsible forsupporting the local implementation and operation of the GMPQuality Management System. The role aims to ensure the site remainsin a state of GMP compliance by participation in investigations,audits, data reviews, validation projects and the delivery of GMPrelated training, etc. This role is a trainee position; therefore,the following duties will requiretraining/supervision:                                                             Responsibilities willinclude:Performs a preliminary regulatory review to providerecommendations regarding the compliance status of study relateddocumentation (i.e. protocols, reports, certificates of analysis,etc) prior to QA approvalReviews and approves site quality documents (StandardOperating Procedures (SOP's), Policies, etc.) to ensure compliancewith GMP, Covance document management procedures and otherapplicable qualitystandardsSupports the GMP QA internal audit programme byparticipating as trainee in audits of GMP-related systems,processes and facilitiesParticipates in projects as trainee to ensuresfacilities, utilities, equipment and computer systems areappropriatelyvalidated/qualifiedReview of metrology methods and specifications foraccuracy/relevance and compliance with appropriatestandardsParticipates as a trainee in investigations (deviations,OOS, customer complaints, etc.) assisting senior GMP QA personnelto assign cause and resolution of qualitydefectsParticipates as a trainee to continual improvementinitiatives aimed at improving the efficiency/ effectiveness of GMPoperationsDelivery of basic GMP training in duecourseEducation/Qualifications:A minimum of a Bachelors Degree or equivalent in aPharmacy, Chemistry or Biology relateddiscipline.Experience:Good communication, decision making, negotiating, andproblem solving skillsExperience in GMP / GLP or similar regulations - likelyfrom a lab environment.Customer service orientated, i.e. ability tointeract effectively withclientsExperience in process improvementpreferableAbility to work under minimalsupervisionComputerliterateGood verbal and written communication inEnglish

Compartir:
Compartir: