We are looking for a Quality and Compliance Consultant with a ‘can do’ attitude who wants to work within a global biopharmaceutical company. Interested? Please contact us!
The Quality and Compliance Consultant is responsible for ensuring that a quality management system is implemented and maintained for the distribution activities in Benelux.
- Lead the implementation and maintenance of the quality system, including the organization and the documentation and tracking the completion milestones.
- Deal with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
- Impact and influence the organization by communicating quality issues and decisions which impact the business.
- Ensure compliance of suppliers Third Party Distribution to all requirements including distribution and transportation.
- Ensure continuous improvement activities for more effective Quality systems across the organization.
- Active participation to company business growth objectives for quality alignment
Ensure that a Quality Management System is implemented and maintained in the local affiliate, including:
Acts as the local Responsible Person delegate, responsible for GDP in accordance with local legislation for the Market
Maintenance of Quality System Documentation: procedures and records
Policy/Directives/SOPs &WI assessment and implementation
GDP and Local regulations impact assessment and implementation
Quality Unit activities definition
Training of personnel: initial and continuous training programs are implemented and maintained, including product identification and avoidance of falsified
Develop and maintain locally the Quality Manual
Ensure that relevant customer complaints are dealt with effectively
Performing Self-inspections at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
System to investigate Deviation and to manage CAPA
Change Control management system
Lead the Quality Council of the local affiliate, as back-up when necessary
Implement adequate action plans for metrics achievement when necessary
Ensures implementation of following Quality Operations:
Supports the Suppliers management oversight
Supports the Customers qualification process
Supports Responsible Person and back-up Responsible Person with Product Quality Administrative Batch Release
Supports quality issues with the impacted market team
Coordinates and promptly perform any market action operation, recall, for medicinal products. Mock recalls
Support implementation of requirements in the Local Belgian/Dutch Distribution Centers for:
Secondary packaging facilities
Quality Risk Management
Support the coordination and preparation of Quality Risk Management
Inspections and Regulatory Surveillance
Support the Global Quality Audits in the market
Support preparation of HA inspection in local entity
- A Master’s degree in Pharmaceutical Sciences (or in (Veterinary) Medicine, Chemistry, Biology, Biomedical), as defined in Art.95 § 2 of the RD of 14 Dec 2006
- 3-5 years of progressive experience within the quality function of the pharmaceutical health care industry.
- Knowledge and experience in pharmaceutical health care distribution, operations, quality assurance, and international regulations are essential.
- Knowledge in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies, and requirements for pharmaceutical products distribution.
- Fluent in ENG/FR/Dutch
- Strong working knowledge in PCs (experienced in Excel, Word, PowerPoint and SAP) and in Quality Systems
- Team oriented worker with excellent interpersonal skills.
- Ability to actively participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.