Candidate must have 2-5 years maximum experience of working in a Hospital/Industrial or a Community Pharmacy setting at a senior level or can easily demonstrate where they have excelled within their current role.
Life Scientific Ltd, based in South Dublin, specialise in the development and registration of off-patent plant protection products. As part of our ongoing expansion into new European markets, we have an exciting opportunity for a Regulatory Affairs Executive.
The Associate Director, CMC Coordination within External Quality leads a sub-team of Specialists in compiling global CMC submissions and responses to regulatory agency inquiries for all of Alexion’s clinical and commercial products.
The principle responsibility of the Global Supply Planning Director is to effectively plan drug substance, drug product and finished product across a global manufacturing network to ensure continuity of supply to patients.
The Computer System Validation (CSV) Engineer performs activities to support the local automation teams and manage all computerized system validation activities in Alexions cGMP vial fill finish manufacturing plant in Athlone, Ireland and Alexions cGMP packaging plan in Dublin.
The successful candidate will be responsible for providing technical support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing.
The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug product manufacturing operations performed at CMOs remotely while based here in Dublin.
The Senior Specialist, Analytical Method Transfer is responsible for coordination of method transfers including ELISAs, cell-based assays, enzymatic activity assays and traditional chemistry methods between Alexion and Contract Laboratories
The Warehouse Supervisor is responsible for the management and co-ordination of day to day warehouse activities at the Dublin facility.
The SAP QM Functional Analyst Lead will manage the entire application life cycle in the area of SAP Quality Management (QM) with process expertise in inspection, result monitoring, defect management, traceability and all relevant GXP compliance aspects within the existing SAP ECC 6 system.
Providing QAV support in our New Packaging Facility which is currently under construction in Dublin.
The Senior Specialist for QA will be responsible, with management support, for providing quality oversight (including validation responsibilities) associated with technical transfer of drug substance and drug product manufacturing processes to contract manufacturing organisations.
A key member of the team responsible for delivery of quality systems oversight for activities at Alexion Ireland to ensure commercial and/or clinical products are manufactured in accordance with all regulatory and corporate requirements.
The Senior Manager of GXP Audit will be responsible for assisting in the development, execution and leadership of the GXP Corporate Audit Function within Alexion.
QC Micro Analyst, to join our growing team in our new Facility in Blanchardstown. Experience of Endotoxin and Sterility testing within a GMP environments is essential.
Snr QA Specialist to join our team in Athlone. Providing QA support to all site functions. Ideally QP release experience too.
We are Hiring Snr QC Specialist x 2 for our new Labs based in Dublin. You will be utilizing HPLC, ELISA, Gel Electrophorisis testing amongst other tests.
An IT Manager has a broad knowledge of client side support, server infrastructure, networks, and communications and is responsible for designing, deploying, and maintaining the company’s infrastructure.
Responsible for the design, deployment, maintenance and administration of data networking technologies at Alexion sites throughout EMEA.
The laboratory based role will be responsible for conducting analytical testing, method validation, transfers and other cGMP required activities as needed. The position is also responsible for authoring protocols and reports associated with these activities.
The laboratory based role will be responsible for conducting analytical testing, conducting investigations, method validation, transfers and other cGMP required activities as needed.
The Customer Operations Senior Manager residing within the Customer Operations & market Development , is responsible for establishing, developing and maintaining successful and mutually beneficial business relationships with Customer Operations Representative within their region.
The primary responsibility of the Data Protection Engineer, Archiving is to design, build and operationally manage all aspects of the global enterprise Archiving environments, including developing and enforcing policies, procedures and productivity standards.
Snr QA Specialist position to support QC and other activities in our new Global Packaging and Distribution Facility. Blanchardstown
The Associate Director has primary responsibility to oversee and manage the business relationship with contract manufacturing organizations (CMOs) used for the supply of drug substance, drug product and finished product including supply contracts and supplier relationships.