QP Senior Quality Manager - Qualified Person- Europe

Location Dublin
Discipline: Quality Assurance
Job type: Permanent
Salary: £60000 to £80000
Contact name: Katie Dunbar

Contact email: katie.dunbar@rbwconsulting.com
Contact phone: +44 1293 584 300
Job ref: 22544
Published: 24 days ago
Expiry date: 09 December 2021

My client are seeking an experienced QP to join as Senior Quality Manager, taking responsibility for the review and QP release of product imported for sale in the EU, and providing assurance of quality compliance of the business. This is a small, friendly and supportive company, and this role reports in to the Head of Quality and will include line management of one direct report.

Key Functions of the Role:

Product Batch release

  • QP review and release for product imported from outside of the UK to allow sale of product in the UK.

Supplier / Customer Compliance

  • Ensure Quality Assurance (QA) requirements are met at all times by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in GMP and WDA licences, in order to support business continuity.
  • Ensure Quality Assurance requirements are met for compliance as the Manufacturing Authorisation Holder for products.

Quality System Maintenance & Management

  • Oversight of the management and maintenance of the Quality system (ensuring measures are in place to support good documentation practice and data integrity principles, and effective governance of all company SOPs)
  • Guidance to the business for the awareness of new and revision to existing quality directives within EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use.
  • Manage the QMS performance level to maintain compliance of the MIA systems

Internal Compliance

  • Oversight of employee training records and compliance of employee training with regulatory requirements, (including Controlled Drugs training).
  • Ensure that QP training and continuing professional development are maintained on a personal basis
  • Comply with relevant legal and compliance requirements, regulatory and ethical standards and SOPs.

Line Management

  • Responsible for line management of batch reviewer
  • KPI setting and reporting

 

Essential Qualification and Skill Requirements:

  • Qualified Person (with >3 years’ experience) Specific knowledge is required for solid dose forms (tablets and soft gelatine capsules) Experience with sterile injectables is ideal but not essential.  
  • Continuous Professional development to assure current product knowledge and knowledge of pharmaceutical regulation and regulators.
  • Extensive knowledge of Quality Management systems within a pharmaceutical background.
  • Good inter-personal and communication skills.
  • Ability to work under pressure and remotely to the site of product manufacture and testing.
  • Excellent attention to detail.
  • Ability to prioritise work via effective time management
  • Bilingual, English and Spanish would be highly desirable

 

This is an immediate, permanent role, offering a competitive salary depending on experience, an strong package too. The role will require 2-3 days per week in the office in Dublin and relocation package can be offered.