Quality and Compliance Co-ordinator

  • Location
    Basingstoke, Hampshire
  • Category
    Admin. Secretarial and PA - Administrator
  • Contract Type
    Permanent
  • External Reference
    JN-032020-125981
  • Salary
    25000 £ - 30000 £ / Year














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




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