This role combines package engineering and quality. You'll set the gold standard for finished goods quality, lead internal and external quality initiatives, and be a key voice in ensuring products meet the highest expectations. You will develop relationships with suppliers to identify packaging, create finished good specifications, and drive process improvements.
As a Post-Market Surveillance Analyst, you'll be an essential part of the Quality Team, supporting the operational integrity of the Post-Market Surveillance system within the Quality Management System. You'll meticulously manage the quality of complaint records, ensuring their completeness and consistency prior to closure. The role demands a deep understanding and precise application of diverse regulatory requirements.
Shire Human Genetic Therapies Inc. is seeking a Senior Validation Engineer to write Validation documents per Food Drug Administration (FDA)/Company guidelines; draft Specification documents and Validation Plans (VPs) for pharmaceutical manufacturing and laboratory equipment. The engineer will write and execute qualification protocols for new equipment and decommissioning protocols for old equipment.