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Process Technical Specialist

Manufacturing / Production
Cork
Siobhán Lane
Temporary
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Job Reference: JO-2008-65345_1597843457

Summary:

Responsibilities:


* Provide Technical Support for the commissioning and qualification of the drug substance manufacturing process.


* Work with site support groups to deliver qualified raw materials and consumables for the manufacturing process.


* Support the technology transfer of drug substance manufacturing process through effective collaboration with business partners and customers.


* Author, review and approve manufacturing documentation associated with transferred processes.


* Troubleshoot manufacturing issues and lead investigations through scientific problem-solving approaches.


* Partner with quality groups to support change management for the manufacturing process.


* Generate study plans, protocols and summary reports to support the manufacturing process.


* Establish and lead implementation of the continued process verification program to effectively manage product life cycles.


* Adherence to highest standards for Compliance (Quality and Safety)


* Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, regulatory inspections and incident investigations.


* Actively participate in a culture of Continuous Improvement and process optimisation by deploying Six Sigma tools.


* Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.



Requirements:


* BSc Biochemistry, Microbiology, Chemistry, Engineering or a related field


* 2 years experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience


* Experience in at least two of the following areas protein chemistry, process engineering, cell culture, purification technologies, process operations, statistics, technology transfer, microbiological control of bio-manufacturing processes, cleaning validation, process validation, regulatory inspections.




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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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