Alexion Pharmaceuticals,Inc

About Alexion Pharmaceuticals,Inc

QC Stability Specialist is responsible for developing and maintaining the Stability program within the Quality Control laboratory facility in Dublin and ensures that all activities are fully in compliance with cGMP standards. The QC Stability Specialist is responsible for performing key quality tasks. Principal Responsibilities Primary duties of the position are focused around non-laboratory support of the QC stability function. Primary activities would generally include but be not limited to: Management of stability programs for all products. Enrolling biologics lots into stability studies in LIMS at Alexion, according to stability protocols. Includes registrational stability studies (Process Validation Runs, site-specific stability studies, temperature excursion stability studies, annual enrollment lots and for-cause lots. Enrolling lots into stability studies at contract management organizations according to stability protocols. Writing stability protocols The collection of stability reports, data analysis, data trending/statistical analysis Project management and testing coordination Document revisions (protocols, stability reports and memos) Authoring the stability sections of regulatory filings Completing stability section of annual product quality reports and regulatory updates Initiating/completing quality systems (TrackWise). Project Management to initiate and administer Stability Studies according to cGMP guidelines. Generation of Stability Protocols, Reports and associated Documentation. Statistical Analysis of stability data. Generation of technical documents for regulatory submissions. Lead out-of-specification (OOS), out of trend (OOT) analytical deviations. Lead trending programs for all products on release and stability. Operate CAPA/Deviation, training and compliance systems. Support regulatory submissions as required. Support for Health Authority Inspections. Identify and implement continuous improvement programs as appropriate. Involvement in other QC activities as required. Qualifications An understanding of the methodology and analytical techniques used for biopharmaceutical testing. Excellent communication, interpersonal and organizational skills. Ability to work well both independently and in a team environment. Ability to prioritize work and multitask. Conducts work in compliance with cGMPs, safety and regulatory requirements. Education Degree in chemistry or biological science with a preference for Analytical Chemistry or Biochemistry with a minimum of 4 years’ experience in a related role. Competencies Experience with analytical investigations, change control and documentation management. Works in a collaborative manner and is able to develop excellent working relationships with peers. An understanding of organisational, planning, priority setting and time management. Excellent report writing skills. Takes a structured, analytical approach to problem solving. #LI-GO1 Dublin, Ireland Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.

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Company Info

Legal Form: Inc

Company Type: Public

Company Size: 501 - 1000

Revenue: 1 - 5 billion (CHF)

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Hiring Locations: 17

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