Alexion
OperationSupportSpecialist(Secondment)
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Operation Support Specialist (Secondment) at Alexion. Skills: operations documentation, Vault processes, Trackwise/ EQV processes, investigations, technical writing, deviations, corrective actions, change control, batch records, manufacturing process records, raw materials, consumables, continuous improvement initiatives, Regulatory licensure activities, agency inspections, submission preparations, inspection responses, process related changes, Audit preparation, GMP compliant state, operational”
Industry & Context.
Good interpersonal, communication and problem solving skills
What They're Looking For.
Must 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
Nice to Have
BASc. in a scientific discipline or equivalent experience preferred., 4 years’ experience in operations in a GMP environment with demonstrated technical investigational ability
What You'll Do.
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
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
How You'll Work.
Communication Scope
Good interpersonal, communication and problem solving skills
Full Job Description
**This is 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. The individual in this position is expected to represent Alexion Pharmaceutical interests, objectives and policies in a professional and responsible manner. **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 * E
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