Quality and Compliance Consultant – 6 months Contract Position – Belgium
At Clintec, we understand that where people’s lives are involved, there’s always more to be done and innovation to be discovered. We have a focused, flexible and forward-thinking approach; turning ideas in to reality to meet patient needs and bring new medicines to market.
We currently have exciting opportunities for Quality and Compliance Consultants to join the team in Belgium. This position is a contract position initially for 6 months, working office based Belgium.
Quality and Compliance Consultant responsible for ensuring that a quality management system is implemented and maintained for the distribution activities with Bristol-Myers Squibb products in Benelux.
Expected area of competence:
Leads the implementation and maintenance of the quality system, including the organization and the documentation and tracking the completion milestones.
Deals with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements.
Impacts and influences the organization by communicating quality issues and decisions which impact the business.
Ensures compliance of suppliers Third Party Distribution to all BMS requirements including distribution and transportation.
Ensures continuous improvement activities for more effective Quality systems across the organization.
Active participation to company business growth objectives for quality alignment.
Key Responsibilities and Major Duties
1.1 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
BMS 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
1.2 Quality Operations:
System for suppliers management: Quality Agreements, approving any subcontracted activities which may impact on the product quality
Customer qualification management
Material Quality status and administrative batch release
Analytical transfer coordination/approval to meet product launch
Handle compliance/quality issues with the impacted local affiliate team, within the global networks of Quality Assurance
Attend the fact finding when required and define the adequate action plans with In market
Manage On Hold products request
Coordinating and promptly performing any recall operations for medicinal products. Mock recalls
Decision on the final disposition of returned, rejected, recalled or falsified products
Approval the returns to saleable stock, according to BMS guidelines
Support Supply Chain to avoid Back Orders
Shortage communication to HA, according to established process
Medical samples Quality distribution oversight
Support of sampling requested by HA (product, procedures, reference substances)
Keeping appropriate records of any delegated duties
1.3 Facilitate the implementation of BMS requirements in the Local Distribution Centre for :
Secondary packaging facilities
1.4 Quality Risk Management
Coordination and preparation of Quality Risk Management
Participate in the periodic Business Review with the DC
1.5 Inspections and Regulatory Surveillance
Maintaining the Wholesale Distributor License, Specials licenses with Regulatory agencies
Import certificates when requested
Preparation of Health Authorities (HA) inspection in local entity and leading in HA inspection
With 100% FTE presence a week at BMS Offices, potential requirement to travel to the BMS NL offices in Utrecht upon request for business needs
BeNelux (Belgium primary location, occasional travel to Netherlands
Click Apply Now to send your CV of email us directly on firstname.lastname@example.org for more information
Clintec (an IQVIA company), established for 22 years, is an award-winning, full-service global clinical research organisation with our HQ office based in Scotland, UK. We support key product development and manage clinical trials in over 50 countries worldwide, across all major therapeutic areas, with expertise in Oncology and Rare Disease studies. We differ from other players in the clinical research industry as we combine the agility and flexibility typical of smaller CROs with the global coverage and management associated with large CROs.
Find out more by visiting www.clintec.com