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June 20 2018

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Job Offer: Sterility Assurance Lead:Alexion Pharmaceuticals

Job description:

Sterility Assurance Lead

Alexion Pharmaceuticals

   » Roscommon
   » See description
   » Permanent full-time
   » Updated 14/06/2018
   » HR this job is expired SaveSave Apply Now

Job detail

The Sterility Assurance Manager position provides microbiological oversight to global operations including drug substance and drug product manufacturing

Sterility Assurance Lead

Reports to:
Director, Quality Control

Job location:

Position Summary
The Sterility AssuranceLead position provides microbiological oversight to global operations including drug substance and drug product manufacturing at both Alexion and external manufacturing facilities and contract test labs
This position will support execution and implementation of activities for the microbial control of manufacturing including execution of quality risk management, on-site training and reporting on key sterility assurance metrics. Information technology requires an overall knowledge of manufacturing processes for biotechnology sterile products and connected testing
this function will focus on the sterility assurance support for technical transfer and start-up of biologics drug substance and drug product to internal manufacturing in alignment with Alexion global standards. Additionally Information technology will support sterility assurance of the facilities in a steady state manufacturing environment.

Principal Responsibilities
   » Providing technical oversight for aseptic control for internal and external manufacturing.
   » Leading the sterility assurance program for Alexion operations from upstream and downstream processes and transferring knowledge during technical transfer to internal manufacturing.
   » Manage the alignment of global microbial testing and monitoring programs
   » Execute QRM (quality risk management) of manufacturing processes to identify the risk profile per process and risk mitigation plan.
   » Co-ordinate and execute training for Alexion personnel in Basic Microbiology, Bioburden Control and aseptic best practices.
   » Co-ordinate key sterility assurance metrics for internal and external manufacturing facilities and CMO (contract manufacturing organizations) providing an overview of trends.
   » Support the introduction and maintenance of standards, gap assess existing procedures against approved standards
   » Other tasks including SOP update, protocol review, troubleshooting contaminations, regulatory audit support and on site risk assessment to support the global sterility assurance program.
   » Microbiological testing support: Review connected protocols, final reports, risk assessments, SOPs, deviations, change controls in alignment with standards and regulatory requirements. (Bioburden, endotoxin, sterility tests, media fill validations, harvest assays qualifications and establishment of alert and action limits where applicable).

Qualifications and key competencies
   » Bachelor's degree required; preference given to candidates with advanced degrees and degrees in microbiology or biological sciences
   » A high degree of technical competency in Microbiology methods, sterility assurance and aseptic filling is required.
   » 8-10 years of cGMP practice preferred; consideration will be given to other significant practice and education. Microbiological practice in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment preferable.
   » Demonstrated capability to prosperously collaborate, influence and lead in a matrix organization
   » Excellent communication and interpersonal expertise
   » Proven record in demonstrating agility
   » practice of involvement in technical issue resolution, in a multidisciplinary environment
   » Excellent planning and organizing expertise are required to plan and execute programmes in addition to manage resources and timelines
   » Flexibility to travel is a requirement for this function
Ref: 81649C
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Alexion Pharmaceuticals

5 reviews


   » Alexion International Trading, College Business & Technology Park, Blanchardstown, Dublin 15
   » +353 (0) 1 254 6400


Job Category: Customer Service [ View All Customer Service Jobs ]
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Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Roscommon
Company Type Employer
Post Date: 06/14/2018 / Viewed 9 times
Contact Information
Company: Alexion Pharmaceuticals

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