Qualified Person (QP)

The Qualified Person for Secondary Packaging is responsible for overseeing and certifying the secondary packaging processes of sterile pharmaceutical products. This role ensures compliance with Good Manufacturing Practice (GMP) regulations, company standards, and regulatory requirements.

Quality Assurance and Compliance

• Certify batches of sterile products for release, ensuring compliance with GMP and marketing authorization requirement
• Review and approve batch documentation, including packaging records, analytical data, and manufacturing protocols
• Ensure adherence to quality standards throughout the secondary packaging process
• Participate in internal and external audits, addressing any findings or observations

Regulatory Affairs

• Stay updated on relevant regulations and guidelines, particularly those related to sterile product packaging
• Interpret regulatory requirements and provide guidance on implementation
• Collaborate with regulatory authorities during inspections and respond to queries

Process Oversight

• Oversee secondary packaging operations in the sterile manufacturing environment
• Ensure proper environmental controls are maintained during packaging processes
• Review and approve packaging materials, equipment, and procedures

Risk Management

• Conduct risk assessments related to secondary packaging processes
• Develop and implement risk mitigation strategies
• Address quality issues that may impact patient safety or product integrity

Documentation and Record-Keeping

• Review and approve quality-related documents, including SOPs and change controls
• Ensure accurate and complete documentation of all packaging activities
• Maintain records for regulatory compliance and traceability

Training and Development

• Provide training on GMP principles and quality procedures to packaging personnel
• Foster a culture of quality and continuous improvement within the packaging team

Qualifications and Requirements

• Qualified Person certification as per EU regulations
• Extensive knowledge of GMP, GDP, and regulatory requirements for sterile pharmaceutical products
• Minimum of 1 year experience in pharmaceutical quality assurance, with specific focus on sterile manufacturing and packaging
• Understanding of sterile manufacturing processes and secondary packaging operations
• Excellent analytical and problem-solving skills
• Strong communication and leadership abilities

Other Information

• Onsite 5 days a week
• 40 hours a week
• Location: Eindhoven

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin