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Quality Officer (Pharma) _Machelen

Cette offre d'emploi n'est disponible qu'en néerlandais

1830 MACHELEN (VL.BR.)

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Bachelor

38 h/semaine

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Description de fonction

Our customer is one of the leading global logistics service providers whose Japanese corporation is headquartered in Tokyo. Their services range from air and ocean freight forwarding to cargo, removal services and warehouse operations. Their Belgium Headquarter is located in Machelen, Belgium. For the head office in Machelen they are looking for a Quality Office (Pharma).

Expected task for this position:

Ensure adherence to Good Distribution Practices (GDP) as per FDA, EMA, and other regulations through regular audits of facilities, processes, and documentation.
Implement corrective and preventive actions (CAPAs) for non-compliance issues.
Develop, maintain, and ensure the accuracy and traceability of GDP-related documents, including Standard Operating Procedures (SOPs), work instructions, and quality records.
Manage revisions, approvals, and archival processes.
Conduct quality risk management to identify and mitigate risks to product quality and patient safety.
Perform internal assessments to evaluate the effectiveness of quality systems and processes.
Support investigations into deviations, out-of-specification results, and distribution complaints.
Develop and deliver training programs on GDP requirements, quality systems, and compliance standards.
Provide guidance to personnel to ensure understanding of their roles in maintaining GDP compliance.
Identify opportunities for efficiency improvements in distribution operations while maintaining GDP compliance.
Lead or participate in quality improvement initiatives, root cause analyses, and corrective actions.
Monitor key performance indicators (KPIs) and quality metrics to drive continuous improvement

Profil

PREFERRED SKILLS

Proficiency in developing and maintaining quality documentation, including SOPs and quality records, with a solid understanding of Quality Management System (QMS) principles.
Strong analytical and problem-solving skills, with the ability to conduct risk assessments and manage quality risks effectively.
Excellent verbal and written communication skills, with the ability to collaborate across departments to implement quality initiatives, address compliance issues, and drive continuous improvement.
Ability to lead or participate in quality improvement projects, perform root cause analyses, and implement CAPAs.
Capable of working independently, prioritizing tasks, and managing multiple projects in a fast-paced environment.
Strong time management skills to meet deadlines and respond to regulatory requests, while upholding ethical standards and integrity in all activities.
Commitment to staying updated on industry trends, regulatory changes, and best practices, with a focus on ongoing professional development.
In-depth understanding of GDP regulations and guidelines from authorities like the FDA and EMA.
Proficiency in professional terminology in English and Dutch, with Japanese as an asset.
Knowledge of MS Office.

Offre

BENEFITS

Full-time contract
Attractive salary package, including 13th month
Flexible working hours
Meal vouchers and ecocheques
Hospitalization insurance + group insurance
Transport reimbursement according to CLA PC 226
20 vacation days + 6 ADV days + 1 NXB day after 3 years + 1 CLA day after 1 year
Laptop & phone
Free coffee, tea, water, soup
You will be part of a dynamic team
Benefits Plan (“MyChoice”)

Information

Our client is a leading global logistics service provider. Their services range from air and ocean freight forwarding to cargo handling, removal services, and warehouse operations

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Start People Office Leuven
+32 (0)1 682 71 20
leuven.office@startpeople.be
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