Quality Assurance (Qrp Belgium) Senior Specialist

3+ years

Not Disclosed

Amsterdam Brussels Heist op den Berg Netherlands

10 Nov. 24, 2024

Job Description

Job Type: Full Time Remote Education: MSc./M. Pharm/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description you provided is for the position of Quality Assurance Senior Specialist at Organon for their In-Market Quality Team based in either Belgium or the Netherlands. The primary responsibility is to act as the Quality Responsible Person (QRP), overseeing the quality of medicinal products and ensuring that wholesale operations comply with Good Distribution Practice (GDP).

Here’s a breakdown of the position:

Position Overview:

Role: Quality Assurance Senior Specialist (QRP)
Location: Belgium or the Netherlands
Reports to: Cluster Lead ME-PEI
Primary Responsibility: Ensuring compliance with Good Distribution Practices (GDP) for the wholesale of medicinal products, managing quality issues, and overseeing the execution of local quality processes.

Key Responsibilities:

Quality Management Systems (QMS):
- Develop, implement, and maintain local QMS procedures.
- Approve and review local procedures with a quality impact.
- Ensure personnel are trained in quality processes and assess the effectiveness of training programs.
Product Quality Complaints (PQC):
- Manage and ensure effective handling of PQCs, including routing complaints and samples to the manufacturing site, and tracking trending.
Handling Counterfeit, Diversion, and Tampering (CDT):
- Oversee the management of suspect counterfeit products and ensure proper handling according to local regulatory requirements.
- Manage Physician Samples distribution, storage, and tracking.
Product Recalls:
- Coordinate and execute recalls for defective or non-compliant products.
- Make independent decisions on the disposition of returned, rejected, recalled, or falsified products.
Quality Reviews and Deviation Management:
- Review and manage Product Quality Reviews (PQRs).
- Track and trend deviations and corrective and preventive actions (CAPAs).
Temperature Excursions:
- Ensure that temperature excursions during transport, warehousing, and distribution are properly handled.
Change Control:
- Ensure the Change Control procedure is properly applied.
Oversight of Third-Party Providers:
- Review and approve Quality Agreements with subcontractors and third-party logistics providers (3PLs).
- Ensure that 3PL operations (e.g., incoming inspection, storage, and distribution) comply with regulatory requirements and Organon standards.
Medical Devices Conformity:
- Ensure conformity checks for medical devices as per the MedDO (Medical Devices Ordinance).

Required Education, Experience, and Skills:

Education:
- Higher education (e.g., Master’s degree) in pharmaceutical, chemical, biological sciences, or a related field.
Experience:
- At least 3 years of experience in Quality Assurance in the pharmaceutical industry.
- Experience in GDP, and preferably GMP, Swiss pharmaceutical regulations, and medical devices regulations.
- Knowledge of Quality Management Systems and the application of risk management.
Skills:
- Experience using applications such as SAP, eQMS solutions, and eLearning systems is a plus.
- Strong communication and interpersonal skills, capable of fostering collaboration across functions.
- Problem-solving and decision-making capabilities, with a good understanding of regulatory requirements.
Languages:
- Fluent in English.
- Proficiency in French and/or Dutch is a plus.

About Organon:

Organon is a global healthcare company committed to improving the lives of women, their families, and communities. With a focus on Women’s Health, biosimilars, and a diverse portfolio of health solutions, Organon aims to deliver solutions that enable people to live healthier lives.

If you’re interested in applying or need further assistance with tailoring a resume or cover letter for this position, let me know!

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Quality Assurance (Qrp Belgium) Senior Specialist

Job Description

Position Overview:

Key Responsibilities:

Required Education, Experience, and Skills:

About Organon:

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