Candidates login or register below

Like Us

Candidate Login / Register
Sorry, but this job has expired. Please try another search or browse our jobs.

Quality and Compliance Consultant

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
QA Jobs
Country:
Belgium
Region:
Belgium All
Contract Type:
Permanent
Currency:
Unspecified
Salary Description:
Competitive
Posted:
06-Mar-20
Recruiter:
Clintec
Job Ref:
3702

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.

THE ROLE:

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 :

Warehousing facilities

Secondary packaging facilities

Transportation processes

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

1.6 Territory

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 careers@clintec.com for more information

THE COMPANY

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

Closing Date:
04/04/2020

Return to search.

This website uses cookies. Read our cookie policy for more information. By continuing to browse this site you are agreeing to our use of cookies.

Latest Job Listings