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.Responsibilities
Compliance Oversight
Monitor and ensure compliance with relevant regulatory standards and guidelines such as ISO, FAVV, and other industry-specific regulations.
Conduct regular audits and inspections of processes, facilities, and documentation to verify adherence to compliance requirements.
Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs) for any identified non-compliance issues.
Documentation Management
Review and maintain documentation related to compliance and quality assurance, including Standard Operating Procedures (SOPs), work instructions, and quality records.
Ensure accuracy, completeness, and traceability of documentation related to operations, including internal audits and corrective actions.
Implement document control processes to manage revisions, approvals, and archival of quality documentation.
Quality Assurance Activities
Perform risk assessments and quality risk management activities to identify and mitigate potential risks to service quality and operational integrity.
Conduct internal quality reviews and assessments to evaluate the effectiveness of quality systems and processes.
Support the investigation of deviations, out-of-specification results, and customer complaints, ensuring timely resolution and proper documentation.
Training and Education
Deliver training programs on regulatory requirements, quality systems, and compliance standards for employees.
Provide guidance and support all employees to ensure a thorough understanding of their roles and responsibilities in maintaining compliance.
Stay updated on industry trends, regulatory changes, and best practices related to quality management.
Continuous Improvement
Identify opportunities for process optimization and efficiency improvements while maintaining compliance with regulatory standards.
Lead or participate in quality improvement initiatives, root cause analyses, and implementation of corrections.
Monitor key performance indicators (KPIs) and quality metrics to assess the effectiveness of quality systems and drive continuous improvement efforts.
RequirementsQualifications and education requirements
Regulatory Knowledge
In-depth understanding of ISO standards, regulations and guidelines issued by regulatory authorities such as the FAVV, and other relevant agencies.
Knowledge of document control processes, deviation management, CAPA systems, and quality recordkeeping practices.
Quality Management Systems (QMS)
Knowledge of QMS principles and practices and experience in developing and maintaining quality documentation, including Standard Operating Procedures (SOPs), and quality records.
Training and Education
Experience in delivering training programs on quality systems, and compliance standards.
Languages: 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 plus.
Knowledge of relevant industry-specific technologies and trends.
Preferred skills
Analytical Skills
Strong analytical and problem-solving skills to assess complex situations, identify root causes of quality issues, and propose effective solutions.
Attention to detail and data-driven decision-making to ensure accuracy and integrity in quality-related documentation and activities.
Communication and Collaboration
Excellent communication skills, both verbal and written, to effectively communicate with cross-functional teams, management, and regulatory authorities.
Ability to collaborate with stakeholders across different departments to implement quality initiatives, address compliance issues, and drive continuous improvement.
Interpersonal skills to build relationships and foster a culture of quality and compliance within the organization.
Proactive mindset for continuous improvement.
Adaptability and Time Management
Ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast-paced environment.
Flexibility to adapt to changing priorities, regulations, and business needs while maintaining focus on quality and compliance objectives.
Time management skills to meet deadlines of quality-related activities.
Ethical Conduct and Integrity
Commitment to upholding ethical standards and integrity in all quality-related activities, including adherence to regulatory requirements and company policies.
Awareness of potential conflicts of interest or ethical dilemmas and ability to address them with professionalism and transparency.
Continuous Learning and Professional Development
Willingness to stay updated on industry trends, regulatory changes, and best practices in pharmaceutical quality and distribution.
Commitment to ongoing professional development (fe. training, certifications, industry conferences).
Benefits
Full-time contract, undetermined time.
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.
