Sterile Operations Specialist
6 days ago
About Our Team
We are a dynamic and innovative team of professionals who are passionate about developing and manufacturing high-quality medicines. Our team is dedicated to delivering exceptional results and exceeding customer expectations.
We are seeking a highly skilled Sterile Operations Specialist - Biologics to join our team at our state-of-the-art facility in Cruiserath, Ireland. As a key member of our Quality Assurance Technical Operations team, you will be responsible for ensuring the smooth operation of our commercial and clinical sterile drug product manufacturing operations.
Job Responsibilities
- Provide technical support to start-up activities, GMP operational readiness, and technology transfer programs.
- Partner with the CQV team to deliver the GMP scope of work associated with the startup of sterile drug product operations.
- Support technology transfer activities, including QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation, and technology transfer documentation for manufacturing operations.
- Collaborate with functional areas for technical transfer and qualification to ensure knowledge transfer and robustness of control strategies.
- Support the development and execution of training programs in support of multiproduct manufacturing.
- Provide QA Technical Operations support to manufacture commercial and clinical sterile drug product.
- Quality oversight of Product Lifecycle Management Changes (LCMs), equipment upgrades, automation upgrades, process improvements, including recipe updates.
- Quality oversight of Requalification's, revalidations, and periodic reviews.
- Quality oversight of Major deviations, CAPA's, EV's, Change Controls, and Risk Assessments.
- Participation in internal, corporate, and regulatory inspections.
- Drive and support a culture of continuous improvement initiatives and safe working practices.
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