Quality & Compliance Officer (all genders)

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

Requirements
Qualifications 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
• Laptop, mobile phone and subscription
• Free coffee, tea, water, soup
• You will be part of a dynamic team
• Benefits Plan ("MyChoice")

Acquisition in response to this vacancy is not appreciated.