Responsible Person

Responsible Person

The Responsible Person ensures that the Guidelines on Good Distribution Practice (GDP)

- of Medicinal Products for Human / Veterinary use

- for Active Substances for Medicinal Products for Human / Veterinary use

- for Medical Devices

are adhered to and will carry out all responsibilities that are legally assigned to this function. Primary objectives for the Responsible Person include:

• ensuring that AbbVie’s quality management system is implemented and maintained
• focusing on the management of authorized activities and the accuracy and quality of records
• ensuring that initial and continuous training programs are implemented and maintained
• coordinating and promptly performing any recall operations for medicinal products
• ensuring that relevant customer complaints are dealt with effectively
• ensuring that suppliers and customers are approved
• approving any subcontracted activities which may impact on GDP
• ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
• keeping appropriate records of any delegated duties
• deciding on the final disposition of returned, rejected, recalled, or falsified products
• approving any returns to saleable stock
• ensuring that any additional requirements imposed on certain products by national law are adhered
• ensuring that deviations are documented and deciding on CAPA to correct deviations and avoid their reoccurrence and monitoring of the effectiveness of those CAPA

The RP holds responsibility also to AbbVie Logistics B.V. related organizations (e.g. AbbVie Pharmaceuticals B.V.) on the above-mentioned responsibilities.

Job Description

• Provides leadership necessary to ensure that the quality of products and services by 3PL’s meet the highest AbbVie and Regulatory Agency standards.
• Acts as an internal local consultant on the principles of quality assurance and GDP.
• Assists Affiliate QA with quality related product actions (i.e., product QA hold actions, product recalls and market withdrawals) involving products distributed through VLOG.
• Drives process improvement opportunities that focus on reducing costs and prevention of distribution quality issues causing loss of product and/or loss of sales, and on ensuring product quality throughout the supply chain.
• Supervisory or managerial responsibility of QTA with CDC’s.

Qualifications

• University degree is desirable (Bio-Medical Science, Pharmacy)
• 3+ years work experience in a GDP environment is preferred including supervisory or management experience.
• A registration as Responsible Person with the Dutch MOH is preferred
• Knowledge of applicable regulations, quality systems, and principles of quality assurance.
• Experience with Quality systems and Quality Assurance in an operational setting with demonstrated knowledge of techniques for assessing the quality of processes.
• Knowledge of regulations, guidelines and standards related to manufacturing and distribution of medicinal products and medical devices.
• Technical experience in the following areas is desired: logistics, materials management, production, engineering, computer science, quality control/assurance, and compliance/regulatory.
• Proven process improvement and/or product development experience in an industrial setting with demonstration of effective communication, teamwork, problem solving and conflict resolution skills.
• Must possess excellent helicopter view and analytical skills
• Excellent written and oral English communication skills are required

Key Stakeholders:

• MOH
• Local Staff
• Consultants
• Manufacturing sites
• TPM manufacturing sites
• Affiliates and distributors
• Third Party Logistics providers
• Relevant professional societies

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.