Quality and Compliance Co-ordinator

Office Angels ,
Basingstoke, Hampshire
More Details
Job Type: Full-time
Salary: £25,000 per annum

Overview

Working for a well established pharmaceutical company in Basingstoke. Reporting into the Quality Manager. Key Responsibilities are not limited to but will include: · Maintain a product complaint control sheet and communicate details of complaints to the relevant departments and regulatory bodies · Support the administration of product recalls / notifications, maintain a product recall / notification control sheet and communicate details of Field Safety Notices to the relevant departments and regulatory bodies · Review and update regulatory procedures across the Group - specifically UK sites · Liaise with Operational Management, including; Commercial, Customer Service and Warehouse Managers in reviewing and improving processes, standards and delivery of specific projects as required · Assist in the successful completion of Quality audits, including ISO9001, ISO14001, ISO13485, WDA and MHRA and LSAS audits · Supporting the generation of KPIs, reports and minutes for Quality meetings · Ensure product compliance with relevant legislation · Assist with organising and recording training regarding the quality system, applicable standards and regulations across all departments · Conduct internal departmental audits as required · Act as a super-user on the Qualsys EQMS software · Administer HCP agreements · Perform any other ad-hoc duties as required by Management · Ownership of CAPA & the change control process · Point of contact for external audits · Cyclical program of supplier quality documentation · Bona Fides checks of customer purchasing pharmaceutical products · Ownership of reporting on WEEE and packaging compliance to relevant authorities Capable of dealing with all complaints / issues in a professional, efficient and confidential manner, ensuring that any non-compliance is immediately acted upon. Strong organisational skills with the ability to multi-task Excellent time management skills with an ability to plan and prioritise workload Excellent communication skills - both written and verbal Ability to work effectively with all levels of the organisation and utilise a team approach to achieve goals and deliverables Excellent attention to detail and accuracy Adaptable and ability to work on own initiative Ability to handle pressure and work to strict deadlines Flexible approach to all areas of the role. · Regulatory and / or Compliance background desired · Experience of working in a fast-paced, highly pressurized environment · High level of computer literacy including a good working knowledge of Microsoft Office · Experience in dealing with regulatory bodies would be an advantage · Experience working Medical Device sector would be a distinct advantage · Experience working with the following Quality Management Systems would be a distinct advantage: o ISO9001:2015 o ISO03485:2016 o MHRA - Wholesale Dealers License · Experience with the following Quality Management Systems would be beneficial o ISO14001:2015 Environmental Management System Office Angels acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. Office Angels UK is an Equal Opportunities Employer. By applying for this role your details will be submitted to Office Angels. Our Candidate Privacy Information Statement explains how we will use your information - please copy and paste the following link in to your browser: https://candidate-privacy

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