Join a Cork based leading biopharmaceutical company's Global Manufacturing, Packaging & Labelling team. In this role, you'll oversee new drug product launches, tech transfers, CMO packaging operations, and GMP documentation for Oral Solid Dose and combination devices.
- Key Responsibilities:
- Packaging Projects & Operations: Lead packaging projects, including new product launches, tech transfers, quality workstreams, and cost-saving initiatives at internal and CMO packaging sites.
- CMO Management: Oversee CMO packaging operations, ensuring compliance with EU requirements.
- Documentation & Compliance: Manage GMP documentation, specifications, and change controls in packaging processes.
- Device & Kit Assembly: Develop and test packaging solutions for combination devices, considering patient needs and regulatory standards.
- Serialization & Regulatory Compliance: Apply serialization standards (EU FMD, DSCSA) and support regulatory documentation review.
- Project Management: Support packaging projects through all lifecycle stages, collaborating with global and cross-functional teams.
- Cost Efficiency & Continuous Improvement: Lead cost-saving initiatives and process improvements in packaging engineering.
- Requirements:
- Degree in Packaging/Device/Quality Engineering or related field.
- Experience in the pharmaceutical, biotech, or related field with knowledge of cGMP, regulatory standards, and packaging processes.
- Proven skills in project and stakeholder management, technical packaging, and documentation.
- Strong teamwork, communication, and organisational skills.
- Demonstrates excellent verbal, written, and interpersonal communication skills.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
