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Mawdsleys
,
Doncaster, South Yorkshire
QA & QP Assistant
Overview
Job Description
An opportunity has arisen within the Quest 22 site for a QA and QP Assistant. The role is a full time permanent position, working 37.5 hours per week. Role * Preproduction * Performing a full check of documentation and samples to ensure that each job is suitable for issue to production. This includes overlabelling, clinical trials, comb-pack processing and third party processing. * Prepare a sample for use as a reference by production staff * QP Assistant * Perform the final product quality check whilst returning the production samples and applying the release labels to the stock * Perform QA checks on packs with an addressograph label applied, prior to QP release * Perform QA reviews of batches prior to QP certification and progress deviations using the eQMS where applicable, notifying the QP of any major deviations * Approval of Batch Packing Records (BPRs), in accordance with QA check-lists in place * Approval of Label placement photographs * Approval of Labels created, in accordance with BNF, cBNF, PGD, or the EMC * Incoming components * Generate component specifications as required for new components * Perform and record checks on incoming components, releasing them for use in Production * Perform Blank Label release for use in Label print * Quarantine area * Maintain the security of the quarantine area by restricting access and ensuring that the quarantine log is completed accurately * Ensure that waste disposal carried out on a regular basis is recorded accurately * Provide a periodic Quarantine report to key personnel across the site * Quality system * Communicate issues identified to the QPs or Production, generating deviations as required * Perform any other ad-hoc and QMS duties as required by either QA Manager or QPs. * Ensuring Quality incidents such as Deviations, for example, are progressed in accordance with set deadlines. * Assist QA Manager, Quality Officers, and QP's in the progression of deviations found during QA reviews. * Any other tasks as required by the QA Manager Qualifications & Experience * Good standard of written and spoken English * GCSE English and Maths grade A-C or equivalent * Good working knowledge of Microsoft Word packages (Word and Excel) * Experience of working within pharmaceutical quality systems and Good Manufacturing Practice (GMP) an advantage. Personal attributes * Able to demonstrate excellent attention to detail * Methodical and thorough * Able to work under own initiative * Able to prioritise workload * A good customer services approach is required * Able to work effectively with other members of QA including QPs, other on site departments and other sites in the Mawdsleys group.