Senior QMS Coordinator

Job Description

OverviewREED Scientific have a fantastic opportunity for an experienced QMS Co-Ordinator to work within a growing Quality and Technical team, reporting to the QMS Manager. You will be seen as confident in QMS systems, having knowledge of specifications, preparation of customer, internal and external audits and promoting quality and compliance within a GMP environment. The ideal candidate will have a strong understanding of BRC and GMP regulations in the context of pharmaceuticals and Quality Assurance activities.Responsibilities- To assist the Quality Systems Manager in ensuring that all activities on the sites follow current Good Manufacturing Practice and company policies to meet business requirements. To work alongside with the following departments to provide quality / technical guidance and expertise in the resolution of quality issues: Operations, Quality Operations, Quality Control, Procurement, Marketing, Sales & Distribution.- Maintaining QMS documentation, focusing on Policies, SOPs, Work Instructions, Test Methods, etc. Manage the review and approval cycle of all controlled documents.- Help in the general standardization of processes, focusing on process mapping and simplifying existing documentation.- To assist in the interpretation of regulatory requirements and to help all departments to mirror them into their associated Policies, SOPs, Work Instructions and Test Methods which will all form the Document System that defines all business activities.- To promote a sense of quality throughout the site and to raise manufacturing performance by helping with the process standardization and eliminate waste caused by unnecessary compliance errors.- Build and maintain good working relationships with Manufacturing. Work with manufacturing personnel to improve compliance and feedback learning.- Carry out staff quality training as necessary- Maintain customer specifications on the customer portals and liaise with Technical Managers to ensure that they are confident that their products comply with the agreed specification.- Prepare for and facilitate customer audits as well as independent industry audits such as BRC and / or SEDEX.Requirements- Excellent written and verbal communication skills are required by the job holder as in the course of the duties.- Flexibility and the capability of working alone with minimal supervision would be a key quality of the ideal candidate.- Good understanding of GMP regulations in the context of pharmaceuticals and Quality Assurance activities, especially relating to GMP documentation and controlled document.- Experience with Validation activities would be a considerate advantage.- Knowledge of GxP guidelines and regulations such as GMP and GDP.- This is a broad, challenging role that requires meticulous attention to detail, strong communication skills and the ability to multitask.- A strong QA & scientific / technical / engineering background and work experience gained in a GMP environment.- Knowledge of QA processes and systems, combined with experience of SOP creation and improvement, would be a strong advantage.- All employees must abide by the company’s Health and Safety policy and comply with the responsibilities for their job as detailed within the policy.