Supply Chain & Logistics Quality Operations
Recruiter in Herent
Contracted warehouse management
• Negotiate the quality agreements between the contract giver and the contract acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of veterinary products
• Point of contact for quality audits and follow up to support contractor development and implementation of audit action plans in a timely manner, based on existing procedures and practices;
• Assure Good Distribution Practices at 3rd party warehouses in all applicable EUAfME markets.
• Manage investigations, CAPAs, Complaints, recalls, returns, Metrics and other quality events/issues at 3rd party warehouses.
• Manage the quality requirements for distribution, transportation, and storage activities managed by third parties, including oversight of contracted 3rd party logistics and transportation service provider companies
• Manage the quality requirements for local delivery and export, to other markets.
• Work with the Sites, SCL, Logistics providers and applicable Affiliates responsible colleagues, to ensure that products are shipped and handled in a compliant and efficient manner
• Perform necessary functions to maintain correct material and lot status within SAP
• Collaborate in the coordination and completion of any recall operations, following Global and local guidelines and procedures
• Ensure that only qualified Contract Service Providers are used
• Maintain robust Deviation management system, Change Control system, Validation, Complaint Handling system
• Ensure validated Temperature Control and Cold Chain systems are implemented and maintained
• Be involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products
3.Reconditioning of product
• Manage the quality aspects of reconditioning operations at contractor to ensure compliance with national requirements.
• Provide approval for Batch protocols where required
• Provide Quality oversight of product reconditioning operations (CAPA’s, complaint management,…)
• Negotiate the quality agreements between the contract giver and the contract acceptor which specifies their respective responsibilities
4.Quality Management systems
• Assure Good Distribution Practices are in line with standards and local regulations
• Participate in developing SCL Guidelines to ensure consistency of standards
• Be a representative during competent authority audits of operations at third parties e.g. contracted warehouses
• Ensure any impact on product is communicated in a timely manner.
• Develops training packages to increase awareness and understanding GDP and associated processes, for roll out to all colleagues in operations, Contract Packaging & labelling and third party LSPs/ CSPs (transporters, customs brokers)
• Manage training curricula for the EUAfME SCL organization and affiliate colleagues
• Accountable for establishing appropriate professional partnerships, agreements and communication processes with in-market teams especially, Supply Chain and Logistics, Regulatory, commercial service to ensure continuously improving quality performance service levels and objectives are achieved in alignment with approved budgets within EUAfME
• Works closely with the team of Affiliate Quality in the markets
- Bachelor’s degree in a Life Science, Pharmaceutical Science, Veterinary, Chemistry, Biology or equivalent;
- Minimum 6 years of relevant operational experience in logistics operations or manufacturing within the Pharmaceutical industry.
- Proven Quality Management experience in Animal Health/Human Health pharmaceutical environment.
- Knowledge of current Good Distribution Practices (GDP) and EU pharmaceutical legislation and regulations.
- Demonstrated success in a Quality Operations Role
- Firm understanding of Quality Management Systems
- Ability to understand and communicate with a wide range of external business models/entities
- Working knowledge of pharmaceutical product transportation channels and LSPs
- Six Sigma Black Belt / Green Belt or Lean Practioner Preferred
- Ability to communicate and influence broadly – especially with external entities
- Ability to analyze data and synthesize to make data driven decisions
- Ability to Develop and Implement Strategic Initiatives
- Business Acuumen
- Process Owner Management
- Change Agent; Passion to win and can be successful in managing a change environment
- Continuous Improvement and break-thru thinking
- Willingness to travel 5%
We offer you a permanent position in an international environment.