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