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February 17 2018

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Job Offer: QC Manager:Alexion Pharmaceuticals

Job description:

QC Manager

Alexion Pharmaceuticals

   » Roscommon
   » See description
   » Permanent full-time
   » Updated 13/02/2018
   » HR this job is expired SaveSave Apply Now

Job detail

he QC Manager, manages all aspects of QC at the Alexion Athlone facility, including continuing facility and laboratory support, new area start-up and transition management into steady state.

Position Summary

The QC Manager, manages all aspects of QC at the Alexion Athlone facility, including continuing facility and laboratory support, new area start-up and transition management into steady state.
The QC Manager will manage a team of QC specialists and QC analysts to support primarily the microbiological and in process activities for Athlone Drug Product and Biologics facility. In addition there will be a requirement to provide limited support of the analytical program for Biologics.
The function is also responsible for implementation and support of the QC technical, regulatory and quality systems.
The position reports directly into the QC Director, Ireland.

Principal Responsibilities

The prosperous candidate will be responsible for:
   » Manage the QC team, to allow the laboratory to execute as an in-process, release and stcapability testing environment in addition to provision of microbiological facility support. this function will also assume accountcapability for non-direct testing activities
   » Manage all network support activities and ensure they are delivered on time and within budget
   » Management of the Quality control team ensuring adherence to the highest standards.
   » Managing schedules and targets to meet regulatory and business requirements.
   » Managing the validation/qualification of Microbiology test methods and test systems to support in process and commercial release testing.
   » Manage the implementation of a paperless lab (SDMS & LIMS).
   » Manage QC inspection readiness for all inspections and represent the QC in audits and inspections
   » Lead the sterility assurance program for the facility with the QC and manufacturing team to implement and maintain a robust aseptic processing and monitoring program.
   » Provide SME support to the Manufacturing and Projects teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness.
   » Represent QC at product and technical team meetings and lead/drive all connected support activities
   » contact between QC test team and all customers both internal and external
   » Support the training strategy for QC, managing the development, operation and evaluation of training/re-training programs
   » Represent and support the laboratories for all Investigations. Manage the timelines and compliance to Alexion Ireland procedures on investigations ensuring compliant, robust approach to LIR (lab investigation reports), Deviations and appropriate CAPA.
   » Lead the tiered communication process for scheduling of tasks in QC to support commercial operations and prioritization. Manage the timely completion of testing and connected data approval to support batch disposition.
   » Lead QC product report out to management, senior management
   » Responsible for QC support of the APQR process and Process Monitoring support
   » Drive process efficiencies, tracking and reporting on improvements including cost, productivity and waste/rework
   » Support management in continual enhancement of the QC strategic plan
   » Managing the team:
   » Implement and ensure team adheres to all HR Policies as appropriate
   » Time management for all QC personnel
   » Personnel development, SMART objective setting and coaching, completing regular One: Ones with all direct reports
   » Headcount maintenance and recruitment including permanent and contingent workers.
   » Recognition is actively practiced by you and your team
   » Develop CI capcapability and utilize CI tools to drive improvements within QC with a particular focus on new technologies.

Qualifications and key competencies
   » B.Sc. degree in biological, /chemical sciences, business, or other related technical degree or equivalent practice in regulated industry.
   » Preferable 5 - 10 years' microbiological practice in quality control in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, 5 years managery practice is preferable.
   » A high degree of technical competency in Microbiology methods, sterility assurance and aseptic filling 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.
Ref: 81315
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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: 02/13/2018 / Viewed 5 times
Contact Information
Company: Alexion Pharmaceuticals

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