What You Will Do
The Operations Support Specialist is responsible for driving support functions related to the drug substance manufacturing operations at the Alexion Athlone Facility and for ensuring that all operational support activities are completed in a safe manner and in compliance with cGMPs and regulatory filings.
You Will Be Responsible For
Manage and coordinate the creation and revision of operations documentation in line with schedule requirements
Act as a Subject Matter Expert in operations related Vault processes and procedural requirements, providing leadership and expertise where required
Act as Subject Matter Expert in Trackwise/ EQV processes, taking the lead in all Operations related investigations and systems including technical writing, deviations, corrective actions and change control, providing leadership and expertise where required
Create and review batch records and other manufacturing process records
Support the approval of raw materials and consumables
Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement and implementing the strategies once approved
Support Regulatory licensure activities including agency inspections and submission preparations. Provide expertise and leadership in formulating inspection responses
Lead and ensure the timely close out of any process related changes
Manage audit preparation ensuring the manufacturing suite and related areas are presented in a GMP compliant state
Troubleshoot and resolve operational problems during processing where required
Support multiple projects including product transfers, new product introductions and new material introductions
You Will Need To Have
Experience with Vault, Trackwise or related documentation system
Experience with SAP or related ERP system
Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
Good interpersonal, communication and problem solving skills
Knowledgeable of regulatory and GMP requirements
We Would Prefer For You To Have
BA/BSc in a scientific discipline or equivalent experience preferred
4 years’ experience in operations in a GMP environment with demonstrated technical investigational ability
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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