As a Quality & Compliance Officer with a focus on regulatory compliance and quality assurance, you will play a pivotal role in ensuring the highest standards of quality and compliance within the organization. This position requires a keen attention to detail, regulatory knowledge, and strong communication skills to uphold the requirements and maintain quality across all operations.ResponsibilitiesCompliance OversightMonitor and ensure compliance with relevant regulatory standards and guidelines such as ISO, FAVV, and other industry-specific regulationsConduct regular audits and inspections of processes, facilities, and documentation to verify adherence to compliance requirementsCollaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) for any identified non-compliance issuesDocumentation ManagementReview and maintain documentation related to compliance and quality assurance, including Standard Operating Procedures (SOPs), work instructions, and quality recordsEnsure accuracy, completeness, and traceability of documentation related to operations, including internal audits and corrective actionsImplement document control processes to manage revisions, approvals, and archival of quality documentationQuality Assurance ActivitiesPerform risk assessments and quality risk management activities to identify and mitigate potential risks to service quality and operational integrityConduct 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, ensuring timely resolution and proper documentationTraining and EducationDeliver training programs on regulatory requirements, quality systems, and compliance standards for employeesProvide guidance and support all employees to ensure a thorough understanding of their roles and responsibilities in maintaining complianceStay updated on industry trends, regulatory changes, and best practices related to quality managementContinuous ImprovementIdentify opportunities for process optimization and efficiency improvements while maintaining compliance with regulatory standardsLead or participate in quality improvement initiatives, root cause analyses, and implementation of correctionsMonitor key performance indicators (KPIs) and quality metrics to assess the effectiveness of quality systems and drive continuous improvement effortsRequirementsQualifications and education requirementsRegulatory KnowledgeIn-depth understanding of ISO standards, regulations and guidelines issued by regulatory authorities such as the FAVV, and other relevant agenciesKnowledge of document control processes, deviation management, CAPA systems, and quality recordkeeping practicesQuality Management Systems (QMS)Knowledge of QMS principles and practices and experience in developing and maintaining quality documentation, including Standard Operating Procedures (SOPs), and quality recordsTraining and EducationExperience in delivering training programs on quality systems, and compliance standardsLanguages: Professional terminology in ENG, NL.Familiar with a variety of the field's concepts, practices and procedures.Familiarity with MS Office, data analysis and visualization tools are a plusKnowledge of relevant industry-specific technologies and trendsPreferred SkillsAnalytical SkillsStrong analytical and problem-solving skills to assess complex situations, identify root causes of quality issues, and propose effective solutionsAttention to detail and data-driven decision-making to ensure accuracy and integrity in quality-related documentation and activitiesCommunication and CollaborationExcellent communication skills, both verbal and written, to effectively communicate with cross-functional teams, management, and regulatory authoritiesAbility to collaborate with stakeholders across different departments to implement quality initiatives, address compliance issues, and drive continuous improvementInterpersonal skills to build relationships and foster a culture of quality and compliance within the organizationProactive mindset for continuous improvementAdaptability and Time ManagementAbility to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environmentFlexibility to adapt to changing priorities, regulations, and business needs while maintaining focus on quality and compliance objectivesTime management skills to meet deadlines of quality-related activitiesEthical Conduct and IntegrityCommitment to upholding ethical standards and integrity in all quality-related activities, including adherence to regulatory requirements and company policiesAwareness of potential conflicts of interest or ethical dilemmas and ability to address them with professionalism and transparencyContinuous Learning and Professional DevelopmentWillingness to stay updated on industry trends, regulatory changes, and best practices in pharmaceutical quality and distributionCommitment to ongoing professional development (fe. training, certifications, industry conferences)BenefitsFull-time contract, undetermined timeAttractive salary package, including 13th monthFlexible working hoursMeal vouchers and ecochequesHospitalization insurance + group insuranceTransport reimbursement according to CLA PC 22620 vacation days + 6 ADV days + 1 NXB day after 3 years + 1 CLA day after 1 yearLaptop, mobile phone and subscriptionFree coffee, tea, water, soupYou will be part of a dynamic teamBenefits Plan ("MyChoice")Acquisition in response to this vacancy is not appreciated.