As a Quality Officer specializing with a focus on Good Distribution Practices (GDP), you will play a crucial role in ensuring the highest standards of quality and compliance within the pharmaceutical distribution process. This role requires meticulous attention to detail, strong regulatory knowledge, and effective communication skills to uphold regulatory requirements and maintain product integrity throughout the supply chain.Compliance OversightMonitor and ensure compliance with Good Distribution Practices (GDP) regulations, guidelines, and standards set forth by regulatory authorities such as the FDA, EMA, and other relevant agenciesConduct regular audits and inspections of facilities, processes, and documentation to verify adherence to GDP requirementsCollaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) to address any identified non-compliance issuesDocumentation managementDevelop, review, and maintain documentation related to GDP compliance, including Standard Operating Procedures (SOPs), work instructions, and quality recordsEnsure accuracy, completeness, and traceability of documentation related to the distribution process, including shipping documents, and temperature logsImplement document control processes to manage revisions, approvals, and archival of quality documentationQuality AssurancePerform risk assessments and quality risk management activities to identify and mitigate potential risks to product quality and patient safetyConduct internal quality reviews and assessments to evaluate the effectiveness of quality systems and processesSupport the investigation of deviations, out-of-specification results, and customer complaints related to distribution activities, ensuring timely resolution and appropriate documentationTraining and EducationDevelop and deliver training programs on GDP requirements, quality systems, and compliance standards for employees involved in the distribution processProvide guidance and support to personnel to ensure a thorough understanding of their roles and responsibilities in maintaining GDP complianceContinuous ImprovementIdentify opportunities for process optimization and efficiency improvements within the distribution operations while maintaining compliance with GDP regulationsLead or participate in quality improvement initiatives, root cause analyses, and implementation of corrective actions to enhance overall quality performanceMonitor key performance indicators (KPIs) and quality metrics to assess the effectiveness of quality systems and drive continuous improvement effortsRequirementsDeveloping and maintaining quality documentation, including Standard Operating Procedures (SOPs), and quality recordsKnowledge of QMS principles and practices to ensure effective management of quality processes and systemsStrong analytical and problem-solving skillsAbility to conduct risk assessments and quality risk management activitiesAttention to detail and data-driven decision-makingExcellent communication skills, both verbal and writtenAbility to collaborate with stakeholders across different departments to implement quality initiatives, address compliance issues, and drive continuous improvementAbility to lead or participate in quality improvement projects, root cause analyses, and implementation of corrective and preventive actions (CAPAs)Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environmentTime management skills to meet deadlines, respond to regulatory requests, and ensure timely completion of quality-related activitiesCommitment to upholding ethical standards and integrity in all quality-related activitiesWillingness to stay updated on industry trends, regulatory changes, and best practices in pharmaceutical quality and distributionCommitment to ongoing professional development through trainingIn-depth understanding of Good Distribution Practices (GDP) regulations and guidelines issued by regulatory authorities such as the FDA, EMA, and other relevant agenciesProfessional terminology in ENG and NL. Japanese is an assetKnowledge of MS OfficeBenefitsFull-time contract, undetermined timeAttractive salary package, including 13th monthMeal vouchers and ecochequesHospitalization insurance + group insuranceTransport reimbursement according to CLA PC 22620 holidays + > 10 extra daysMobile phone + subscriptionFree coffee, tea, water, soupYou will be part of a dynamic teamBenefits Plan ("MyChoice")Acquisition in response to this vacancy is not appreciated.