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.