We are looking for a Distribution Compliance Specialist for one of our clients based in Braine-l’Alleud.
Don't hesitate to contact me: delphine.vanriet@professionals.randstad.be
We are looking for a Distribution Compliance Specialist for one of our clients based in Braine-l’Alleud.
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Don't hesitate to contact me: delphine.vanriet@professionals.randstad.bekey responsibilities
Assure Distribution compliance using best practices in Risk Management/Serve patient needs/Protect the company reputation/Drive business value :
- Act as subject matter expert (SME) for documenting "shipping qualification" protocols and reports in reference with thermal and mechanical aspects for packaging systems used within logistics.
- Provide SME support and training to key stakeholders including markets, CMO's, Quality teams etc.
- Assure pro-active risk management by deploying comprehensive risk assessments for key areas and make sure response plans are followed.
- Drive cost and CO2 reduction improvement of shipping systems and implement new shipping systems solutions in relation with the business needs.
- Ensure audit readiness including GDP inspection (MHRA, FDA, country specific ANVISA,...) and internal and external audit (Customers, Corporate,...) readiness at all times and act as SME during these inspections and audits.
Shipping qualification accountabilities:
- Drive and coordinate the product shipping risk analysis and transport conditions assessment per product.
- Drive and coordinate shipping qualification of passive and active shipping systems for new products launches or new businesses (new primary, secondary or tertiary packaging or new product flows).
Cold chain accountabilities:
- Revise and maintain standard operating procedures in collaboration with local stakeholders.
- Define data flows in the system, reflecting business rules
° Support key processes such as process validation, computer systems validation, equipment qualification, staff training and cultural awareness and document in Procedures and Instructions as needed.
qualifications
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Operational and Tactical Accountabilities
- Master's degree
- Working knowledge of GMP/GDP regulations, implementing procedural control frameworks,and experience with audit/inspection protocols.
- Understands basics of supply chain flow & concepts from long term demand to distribution to the patients (tools, terminology and techniques).
- Ability to manage the “grey zone”, balance multiple priorities
- Able to work without direct supervision; able to work under pressure and within an international team environment
Development and Strategical Accountabilities
Analytic and synthetic approaches to identify optimal solutions to complex system problems.- Self-directed in defining a problem, identifying root cause & correlations, defining solutions and selecting the most appropriate, and checking the effectiveness of the solution post-implementation
Key stakeholders for liaison
Internal: All Global Distribution pillars; In-Market Supply Chain, IM and Site Supply Chain Management, Global Quality Management, Regulatory- External: Logistics Service Providers/Vendors
key benefits
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 a freelancer is also possible.
