Supply Chain & Logistics Quality Operations

Jobomschrijving

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.

2.Logistics management 

• 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 

5. Other 

• 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 

6. Relationships

• 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

Profiel

• 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
• English
• Willingness to travel 5%

Aanbod

We offer you a permanent position in an international environment.