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June 24 2018

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Job Opportunity: QA Specialist:Alexion Pharmaceuticals

Job description:

QA Specialist

Alexion Pharmaceuticals


   » Westmeath
   » Not disclosed
   » Permanent full-time
   » Updated 14/06/2018
   » HR this job is expired SaveSave Apply Now

Job detail


Responsible for delivery of quality assurance activities at the Athlone facility to ensure commercial and/or clinical products are manufactured in conformity with cGMP, Corporate and Regulatory requirements.
 

Position Summary

Responsible for delivery of quality assurance activities at the Athlone facility to ensure commercial and/or clinical products are manufactured in conformity with cGMP, Corporate and Regulatory requirements. this function will supervise the on-going validation compliance of equipment, systems and processes through start-up and in on-going manufacturing for a purification and/or drug product sterile filling facility.
The QA Specialist executes the site QA activities at Alexion Athlone in order to protect the safety, quality and efficacy of our products, thereby ensuring the availcapability of correct, safe product for our Patients, and assuring the security of the company's business and global markets. This key function must ensure effective interaction with other departments and locations regarding GMP Document review and approval. In particular, this will involve partnering with major stakeholders such as Operations, QC, Technical Services and Engineering to optimize patient supply.

Principal Responsibilities

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Provide quality and cGMP input and oversight for all start up project activities through commercial readiness for Biologics and/or Drug Product facility.
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Provide QA support for risk located verification activities. Review and approval of equipment/utilities verification documentation from design to post execution
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Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
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Authoring, review and approval of QA-related procedures
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supervise the effective documentation and tracking of quality management system activities including deviations, change control and CAPAs.
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Review and approve of Validation protocols as required.
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Perform day-to-day tasks, as well as assist with projects that support company objectives and continuous improvement initiatives
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Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).

Qualifications
   » 3-5 years' practice in a QA environment within the pharma industry or a related field
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Strong expertise of cGMP requirements for pharmaceutical manufacturing required.
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practice of sterility assurance for drug substance and/or drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
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Direct practice of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
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Excellent accuracy and attention to detail
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Good expertise of significant computer packages e.g. Trackwise or similar
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Planning and organizing expertise are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
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High level technical expertise including auditing, pharmaceutical manufacturing and regulatory inspection management.
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Excellent interpersonal expertise are required, as is the capability to communicate well, both verbally and written.
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Excellent time management organizational expertise along with a proven capability to multi-task.

Education

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B.Sc. in science/engineering with a minimum of3-5 years' practice in cGMP Quality environment; or equivalent combination of education and practice.


As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. To lgain more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Ref: 81760
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Alexion Pharmaceuticals


   »
5 reviews

 


   » Alexion International Trading, College Business & Technology Park, Blanchardstown, Dublin 15
   » +353 (0) 1 254 6400
   » http://www.alexionpharma.com



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Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Westmeath
Company Type Employer
Post Date: 06/14/2018 / Viewed 17 times
Contact Information
Company: Alexion Pharmaceuticals


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