Jason Johal is currently recruiting for a Quality Assurance Manager to cover the UK and Ireland for a Healthcare company that touches millions of lives every day as their products and services are essential building blocks of global healthcare. This role is focussed on Ensuring the Quality Management System is established, implemented and maintained and is offered on a full time permanent basis at one of their following sites; Northamptonshire, Dublin or Belfast. The position comes with a competitive salary and will involve 10 - 20% UK, Ireland & Nordic travel.
Your main responsibilities in this role will be to:
• Ensure that processes and procedures are in compliance to the Corporate Quality Manual and to ISO 9000 and 13485 requirements
• Ensure regulatory compliance to the applicable regulations in line with UK and Irish legislation/regulatory authority guidance and European requirements as applicable
• Have overall oversight for release of product for distribution via confirmation of manufacturing release certification
• Lead and coordinate Local Complaint Coordinator tasks
• Support log in of complaints in to the Global Complaint Management System (Trackwise or other platform, corporate complaint software) and assign to Central Complaint Management Team (CCM), EMEA Post Market Surveillance as applicable
• Implement and execute Field Actions (FA) and be the FA contact person ensuring implementation and execution of all FAs according to European and local procedures
• Ensure compliance to Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01) and in accordance with Council Directive 93/42/EEC concerning Medical Devices, with amendments, such as 2007/47/EC
• Act as, or oversee the Responsible Person position (Directive 2004/27/EC) on the Wholesale Dealers Licence and direct contact with the Regulatory Authorities
• Ensure that appropriate contacts within the Country and Cluster business, for example, Regulatory Affairs, Vigilance, Pharmacovigilance, Medical Affairs, Warehouse & Distribution are maintained
• Support Supplier QA program for finished goods sourced, including on-site audits of third parties
• Co-ordinate, perform and document internal audits of the CQA aspects. Supervise the performance of corrective actions for deficiencies
• Assure that systems are in place and maintained to train employees in quality system compliance incl. new SOPs (CQA, W&D)
• Manage external quality audits for ISO 9000 and ISO 13485 accreditation
• Ensure the implementation at the country level of the applicable Quality Manual. This involves the monitoring of the performance of the quality management system
• Act as the main point of contact with Competent Authorities for relevant quality-related requests
• Manage budgets
Duties will include:
• Ensuring that the provisions of the license are observed
• Ensuring that the operations do not compromise the quality of medicines
• Ensuring that an adequate quality system is established and maintained
• Overseeing audits of the quality system and to carry out independent audits
• Ensuring full and prompt cooperation with product license holders in the event of recalls
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
• Industry experience of Quality Assurance and Vigilance
• A degree in pharmacy, medicine or human biology (or equivalent)
• Several years experience in distribution, the handling of product quality complaints and Field Actions on drugs or medical devices
• Experience gained as a Responsible Person (GDP) or Qualified Person (GMP), with solid background and experience of this type of role
If successful you will be joining a healthcare company with products and therapies on nearly every floor, in every department, in almost every hospital worldwide. You'll also find them in clinics and in the home and the work you do will have a direct impact on patients lives.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST39557 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 11th July 2017
- Expires: 8th August 2017
- Reference: ST39557