MSD Regional Distribution Center Quality Oversight/ 

Belgium 

730345486

Job Description

Position Overview - Basic Functions & Responsibilities

As aRegional Distribution Centers Quality Oversightrole you will ensure that following core responsibilities are fulfilled:

• Ensuring that products are stored and distributed in accordance with our company's applicable and regulatory requirements to meet both internal and external customer demands, the Product License, GDPs and contractual obligations ;
• Ensuring the quality performance of the external partner (Distribution Center) through direct oversight, support and technical advice, counselling the partners’ site leadership and providing supervision as appropriate. This includes executing permanent audit readiness, tracking partner quality metrics, providing coaching and training; Quality Assurance such as atypical investigations and change control requests. Additionally, providing support to build effective quality systems at the partner supporting continuous improvement activities.

When acting as
Quality Responsible Person Deputy, you will ensure that following core responsibilities are met:

• EnsuringBelgium and EUregulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled (where applicable as per the country distribution model) ;
• Ensuring quality assurance related compliance with all relevant national and international regulations issued by the relevant authorities as well as with our company's internal guidelines and its global Quality Management System (QMS) ;
• Being independent in your decisions with respect to the responsibilities according to legal rules and regulations and having the authority to issue directives within the assigned responsibilities ;
• Ensuring Health Authority (HA) interactions and notifications regarding quality and supplyissues ;
• Informing and interacting with local business and regional QualityManagement ;
• Ensuring that quality perspective is brought into local business initiatives with qualityimpact ;
• Local coordination and execution ofrecalls ;
• Being a primary country contact forQuality Manufacturing Division and our company's in Belgium ;
• Being a primary country contact for Health Authorities' issues pertaining to q

Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use.

Education

• Master's or higher degree in Pharmacy, Chemistry, Biology, Chemical/Bio Engineering or equivalent ;

• Minimum of 3 years' experience in the pharmaceutical industry, with quality and compliance experience ;

• Experience in the application of pharmaceutical Quality Systems and Quality Assurance ;

• Presence the necessary professional requirements to be legally nominated as RP/DP function.

Skills Required

• Quality Risk Management knowledge ;

• Strong interpersonal, communication (both verbally and in writing), collaborative and leadership skills in dealing with a broad variety of cultures to communicate, collaborate and influence ;

• Computer competencies (Microsoft Office, Outlook, Word, Excel, PowerPoint) ;

• Fluency in French and English.

Competencies required for the role

• Willingness to be flexible and to work in a dynamic international environment ;

• Strategic and analytical thinking, problem solving and decision-making skills ;

• Ability to be decisive and influence management with demonstrated leadership skills to drive change in a compliance culture.

Current Contingent Workers apply

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