Job Information
AbbVie Responsible Person in Zwolle, Netherlands
Company Description
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 required
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 Dutch and 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
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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