Senior Quality Specialist
Up to £45,000 dependant on experience.
Hours Monday - Friday (8AM-5PM Monday to Thursday) (8AM-2PM Friday)
KEY DUTIES AND RESPONSIBILITIES:
•Responsible for setting up, maintaining and the continuous improvement of the quality management system as MAH
•Act as the primary quality lead and management oversight for Quality all quality related activities on behalf of the Marketing Authorisation Holder
•Development, management and implementation of the Quality Management System, including GMP & GDP systems, processes and SOP preparations.
•Implementation and maintenance of Quality and Distribution Agreements with third parties, covering GMP, GDP and GCP activities
•Providing quality advise to stakeholder departments in relation to GxP, covering commercial and development activities
•Review and approve third party QMS documentation to ensure compliance with product authorisations and GxP requirements
•Co-ordinate and review change controls
•Manage and support third party audit management including CAPA
•Review and assessment of deviations
•Manage and review/approve the annual product review process
•Support the preparation of Quality Management Reviews and Quality KPIs/metrics information.
•Review documents associated with the manufacture and distribution of products manufactured by third parties, including, but not exclusively, batch manufacturing records, analytical records, validation activity
•Manage and participate in third party audits
•Maintain tracking system for QMS documentation
•Quality review of complaints
•Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and regulatory requirements
•Drive continuous improvement initiatives to enhance the MAH quality system and product quality ensuring compliance to governing regulations.
•Good understanding of GMP and GDP.
•Bachelor’s Degree in Pharmaceutical / Science discipline with 5+ years of experience in quality and regulatory teams within cosmetic and pharmaceutical manufacturing facilities
•Effective oral and written communication skills in English language as well as local language where applicable
•Ability to work independently with direction
•Ability to handle multiple projects
The UK has now left the European Union. Any EU, EEA or Swiss citizens living in the UK that wish to remain in the UK post Brexit need to apply to the EU Settlement Scheme. Although the closing date for applications was 30th Jun 2021, if you have not yet applied but believe that you would qualify under the EU Settlement Scheme, the Home Office have confirmed that they will consider late applications. For further information please see https://www.gov.uk/browse/visas-immigration/eu-eea-swiss