Logistics Quality Operations Consultant

Logistics Quality Operations is accountable for providing quality assurance management of key logistics contractors for our client and for assuring that the productsstored at the Logistics Service Provider premises are stored in accordance with the company and Industry Good Distribution Practices, product registration file and country specific requirements.

The Logistics Quality Operations Consultant provides the Quality Authority and accountability (Quality decision, negotiation and spokesperson).

The Logistics Quality Operations Consultant will operate in close collaboration with the Logistics Service Provider quality organisation, attend and represent the company at Logistics Service Provider quality meetings as well as Business Review Board meetings, supporting complex change and improvement projects, data trending, digital process integration and resolution of complex failure modes and events.

Interested ? Don’t hesitate to take a look at the job description bellow !

megane.libert@professionals.randstad.be

• 
  Experience withGDP mandatory
• Experience in LSP oversight
• Quality background
• Experience with external suppliers/contractors is preferred
• Strong written and spoken command of English language is required as a core requirement, with knowledge of both French and Dutch knowledge desired
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms
• Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA, FAGG, HPRA and WHO) is a requirement.
• Ability to communicate effectively verbally and in writing, good negotiation and influencing skills
• Dynamic, flexible, enthusiastic and eager to learn
• Takes initiative and ownership to deliver on time without compromising on quality
• Ability to work under minimal supervision and in a team
• Able to demonstrate good planning and organization skills.

Consultancy

We offer an attractive salary with extra-legal advantages :

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)A 13th month
• Training
• Etc

A rate as freelance is also possible

The company contributes to improving the health and well-being of people at every stage of their lives. They have built a strong product portfolio that enables prevention as well as treatment and cure for diseases in a wide range of therapeutic areas

• 
  Works collaboratively with Global Supply, Project Teams and External Supply Quality (ESQ) to support qualification and on-boarding activities of Logistics Service Provider
• Leads and conducts Quality due diligence assessments of Logistics Service Provider in support of Business initiatives
• Partners with Project Teams to support new initiatives and new product launches ensuring readiness of both contractor(s) and product(s)
• Lead the development, implementation and support of QA/QC systems for Logistics Service Provider
• Negotiates Quality Agreements
• Provide Quality Leadership of assigned Logistics Service Provider (s) within the Intercompany Organisation logistics network
• Support the individual and holistic needs (Technical, communication and regulatory needs) of the Quality Operations and compliance team members for Intercompany Operations
• Drive the development, implementation and continuous improvement of Quality Systems to support the company,regulatory and industry requirements
• Proactively support regulatory inspections , Intercompany Operations Quality and Logistics Service Provider supporting distribution. Ensure appropriate review/approval of responses to Regulatory Agencies including tracking of CAPA’s within QTS (if required)
• Provide Quality Leadership for significant deviations at Logistics Service Provider that may impact compliance status or require regulatory notifications
• Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities
• Lead quality risk management activities and manage mitigation plans within Logistics Service Provider
• Accountable for the on-time disposition of products with the Logistics Service Provider, supporting the Intercompany Operations Quality team in line with agreed schedule
• Provide Quality leadership for customer complaint investigations associated with logistics operations
• Prepare for and revision of metrics
• Represent Intercompany Operations Quality at Logistics Service Provider quality meetings as well as Business Review Board meetings

Frequent travel is expected (within the country)