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The Manufacturing Support Team provides manufacturing support to complex life-changing biological products. Support new product introductions, investigations, changes, improvement projects, technical training, operational excellence, and documentation. The team provides a key interface between the shift operations teams and day-based cross-functional support.
Reporting into the operations support team, the Warehouse Technologist will provide cross-functional support to the warehouse team. The successful candidate will act as a liaison between the warehouse shift team and the rest of the functions within the business unit.
You will be responsible for:
* Lead, author, and coordinate Good Manufacturing Practice deviations through the quality management system. This will involve leading structured problem-solving of deviations and the identification and implementation of robust CAPA’s.
* Actively monitor and trend investigation and error topics to ensure appropriate and proactive improvements are implemented.
* Assist in maintaining a safe, cGMP compliant work environment at all times.
* Participate in inspection readiness projects and support internal audits and health authority inspections.
* Raise, own, and participate in change controls and improvement projects while meeting the regulatory requirements defined in relevant health authority submissions, cGMPs, and local Health and Safety requirements.
* Perform technical writing to edit and create documents to support Warehouse Operations. Documents will include Standard Operating Procedures, Work Instructions, Competencies, Training Packs, Protocols, Reports, Forms, and other written materials.
* Seek and implement opportunities for Continuous Improvement.
* Assist in stock management and adjustments using the SAP system.
You will need to have:
* A minimum of 5 years’ experience in warehouse operations in a Pharmaceutical or Biopharmaceutical company.
* Good knowledge of GMP/HPRA/FDA regulatory requirements.
* Strong technical writing skills.
* Self-starter with strong communication, problem-solving, and presentation skills.
* Ability to work effectively in a cross-functional environment as well as independently on a consistent basis.
* Proven ability to work well as part of a team and on own with minimum supervision.
* Strong working knowledge of SAP.
* Experience in quality management systems such as Trackwise or Veeva Vault.
Date Posted: 06-Feb-2025
Closing Date: 19-Feb-2025
Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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