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Supply Chain & Logistics Quality Operations

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Laura Schollen
Recruiter in Herent



Laura Schollen
Recruiter in Herent


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.

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