|Listed on:||15th May|
|Salary/Rate:||£25 - £30|
|Contact Name:||Jakub Rurkowski|
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Quality & Compliance Associate - £25/£30 p/h - 6 months Quality & Compliance Associate - £25/£30 p/h - 6 months The work location is based in Stockley Park on 6-months contact duration Pay rate is between £25 - £30 per hour. Purpose * To support the Affiliate Quality Management System (QMS) * Lead the administration of the change control process, commitment tracking and CAPA (corrective/preventative actions) * To support quality assurance projects and continuous improvement activities within the affiliate across all GxP areas * Manage the affiliate compliance training system(s) * Support internal & supplier audits * Affiliate Records Coordinator Role and Responsibilities: Affiliate QMS * Administration of affiliate Standard Operating Procedures (SOPs) and Work Practices (WPs) within the global document management system * Working with Process Owners to support the creation of SOPs and WPs including authoring, process mapping & formatting * Conducting quality and compliance reviews of new procedures - providing feedback to Process Owners * Support & administer the affiliate change control process, and tracking commitment's and CAPA (corrective/preventative actions) * Advise on the development of training materials for new and updated procedures * Participation in and/or leadership at the appropriate fora within the affiliate Governance & Compliance Framework Audits & Inspection Readiness * Participate in delivery on the annual "Quality Plan" for the affiliate including support of the annual audit programme * Support with periodic Quality Review Audits of the affiliate and suppliers to ensure compliance and highlight risks * Support in the preparation for and execution of corporate and Health Authority audits & inspections * Generate reports of appropriate KPIs to demonstrate compliance levels within the affiliate Internal affiliate development (Culture): * As part of the Quality & Compliance team support the continuous education of the whole business on the importance of 'quality' management & support the implementation of best practices * Responsible for delivery of intranet content & relevant communications to the organisation Compliance Training * Ensure the effectiveness of the affiliate quality training processes * Manage the affiliate Compliance Training System(s) - Compliance Wire & FAST including the assignment of local training according to the Affiliate training matrix * Set up new users within the training system and generate their curricula with line managers * Develop & maintain the Affiliate GxP training matrix including a training analysis for new job roles * Prepare and distribute monthly metrics and training completion reports as required * Deliver compliance inductions for all new starters including relevant Code of Practice training for Field Force Records Management * Affiliate Records Coordinator- Leading records retention and ensuring good documentation practices in the affiliate Skills and Knowledge Requirements: * Working knowledge of the quality management principles and applicable GxP areas including: o ABPI and IPHA Code of Practice & Healthcare Compliance o Pharmacovigilance Legislation o Responsibilities of a Wholesale Dealers Authorisation Holder (GDP) * Previous relevant experience within a Pharmaceutical company (ideally at an affiliate) including relevant regulatory experience * Highly organised and efficient. Able to multi task whilst maintaining a very high level of accuracy and attention to detail * Solution orientated with an ability to lead projects and facilitate teams * Experience of participating in audits and/or supporting quality reviews * Established knowledge of good documentation and record retention principles * Life science/pharmacy degree * Good computer skills and good knowledge of Word, Excel, Outlook and Visio If you are relevant or interested don't delay, contact me on [Telephone number removed] or email me at