Quality and Compliance Co-ordinator

  • Location
    Basingstoke, Hampshire
  • Category
    Admin. Secretarial and PA - Administrator
  • Contract Type
  • External Reference
  • 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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